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W. L. GORE & ASSOCIATES, INC. GORE® SYNECOR® INTRAPERITONEAL BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number GKFV1520 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Erosion (1750); Bowel Perforation (2668)
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| Event Date 02/04/2022 |
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Event Type
Injury
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Event Description
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It was reported to gore that the patient underwent robotic assisted parastomal hernia repair on (b)(6) 2020, whereby a gore® synecor intraperitoneal biomaterial was implanted.The complaint alleges that on (b)(6) 2022, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: hernia recurrence, intestinal blockage, organ perforation, adhesions, small bowel obstruction and severe pain.Additional event specific information was not provided.
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Manufacturer Narrative
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Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant preoperative complaints: on (b)(6) 2020: (b)(6) md.Indications: ¿(b)(6) is a 56 y.O.Male presenting for robotic assisted parastomal hernia repair.I had a long discussion with mr.(b)(6) regarding the rationale for a robotic parastomal hernia repair in this setting.We discussed the potential complications of bleeding, infection, injury to surrounding structures, mesh complications, and hernia recurrence.(b)(6) understood and wished to proceed.The patient has received and signed informed consent for this procedure.¿ implant procedure: robotic assisted parastomal hernia repair, extensive lysis of adhesions lasting > 2.5 hrs, insertion of mesh prosthesis measuring 15 x 20 cm.[implant: gore® synecor intraperitoneal biomaterial, gkfv1520/20856679, 15cm x 20cm, oval.] implant date: on (b)(6) 2020 [hospitalization dates not provided] on (b)(6) 2020: (b)(6) md.Operative report.Assistant: (b)(6) md.Preoperative diagnosis: parastomal hernia.Postoperative diagnosis: same, extensive intraabdominal adhesions.Anesthesia: general.Estimated blood loss: 25 ml.Complications: ¿no complications entered in or log.¿ wound classification: not provided.Findings: ¿parastomal defect measuring 4 x 6 cm in diameter containing omentum and colonic mesentery, omentum.Diffuse intraabdominal adhesions throughout entire abdomen requiring extensive lysis of adhesions lasting > 2.5 hr.¿ procedure: ¿the patient was brought to the operating room and placed in the supine position on the operating room table.After adequate general anesthesia had been induced the patient was intubated and mechanically ventilated.A foley catheter was not placed in the bladder and an orogastric tube was placed in the stomach which was decompressed.The patient received a single dose of broad-spectrum antibiotics prior to incision as well as 40 mg of lovenox.The patient's left arm was tucked at his side and his abdomen was prepped and draped in standard surgical fashion.A safety pause was performed.I then used a veress needle entrance technique in the luq to induce pneumoperitoneum to a pressure of 15 mmhg with carbon dioxide.This was successful on the first pass of the needle as indicated by low opening pressures and co2 insufflation rates of 2 l/min.Once pneumoperitoneum had been safely established a robotic 8-mm trocar was placed in the left lateral abdomen using an optiview technique.The 8-mm 30-degree angled laparoscope was then inserted and the abdomen was briefly explored.There was no evidence of veress needle entrance injury.Extensive adhesions were noted within the abdomen and our initial view was limited to the luq only.The veress needle was removed under direct vision.A 12 mm trocar was then placed immediately subcostal, followed by another 8mm trocar in the lateral left mid abdomen.Adhesiolysis was then performed laparoscopically using a combination of cold metzenbaum scissor dissection and blunt dissection with judicious use of cautery.We were able to cevelop [sic] enough working space within the abdomen to place a 3rd extra long 8 mm robotic port in the llq.We were able to identify the parastomal defect and its contents in the rlq.Once this portion of the adhesiolysis was complete taking approximately 1.75 hrs, we brought the robot into the field and docked the robotic trocars.Instruments used in this case included a fenestrated bipolar in the most inferior port, camera mid abdomen and a metzenbaum scissor in the most superior port.Once the instruments were safely inserted into the abdomen i went to the robotic console.Dr.(b)(6) remained bedside throughout [sic] the procedure.I continued adhesiolysis using the robot for another hour or so, until i had reduced all of the non stomal bowel content from the hernia.I did not identify any additional bowel loops within the defect.I then closed the parastomal defect with a running 0 stratafix symmetric suture.The defect was closed in such a fashion as to make the outlet abutting but not compressing the colostomy.I then placed an intraabdominal ruler and sized the mesh.I determined that a 15 x 20 cm synecor mesh would work well for this case.Due to tension on the [sic] mesentery and the fact that the patient¿s sigmoid colostomy had been resited to the rlq, i decided to perform a keyhole repair, rather than a sugarbaker in this case.The mesh was prepared on the mayo stand with a slit on the medial side and a small 3 cm circle cut in the middle.The mesh was rolled and delivered into the abdomen through the 12-mm trocar.The mesh was centered on the colostomy with the slit placed medially.I used some sorbafix tacks to position the mesh then sutured the mesh circumferentially to the abdominal wall using multiple running 2-0 v-loc sutures at the outer edge.The mesh was flat and tight and centered on the stoma.The central mesh defect was then sewn to the stoma using interrupted 2-0 vicryl sutures.Hemostasis was then assured.The robot was undocked and brought away from the field.The 12-mm trocar site was closed with a 0-vicryl suture using a gleich suture pass technique under direct vision.The abdomen was desufflated and all trocars were removed.Incisions were infiltrated with 0.25% marcaine with epinephrine.Incisions were closed using 4-0 monocryl subcuticular sutures.Dermabond glue was used as a sterile dressing on all incisions.The stoma was digitized and found to be widely patent below the fascia.The fascial defect measured 1.5 finger breadths.A new stoma appliance was placed as well as an abdominal binder.The patient was allowed to awaken from anesthesia and extubated without difficulty in the operating room.The patient was transported to the recovery room in stable condition where he will make his early postoperative recovery.I was physically present in the operating room for all portions of this case.¿on (b)(6) 2020: (b)(6) center.Implant record.¿biomaterial intraperitoneal synecor¿.Site: ¿(right) abdomen¿.Cat#: gkfv1520.Lot#: 20856679.Size: 15cm x 20c [sic ].Pathology: pathology report was not provided.Explant preoperative complaints: on (b)(6) 2022 [corrected date]: (b)(6) md.Indications: ¿(b)(6) is a 58 y.O.Male presenting for robotic incisional hernia repair due to a documented small recurrence and subsequent small bowel obstruction.Patient underwent prior robotic assisted repair on (b)(6) 2020.I had a long discussion with mr.(b)(6) regarding the rationale for laparoscopic incisional hernia repair in this setting.We discussed the potential complications of bleeding, infection, injury to surrounding structures, mesh complications, and hernia recurrence.(b)(6) understood and wished to proceed.The [sic] patient has received and signed informed consent for this procedure.¿ explant procedure: attempted robotic assisted incisional hernia repair (aborted), conversion to exploratory laparotomy, extensive lysis of adhesions, takedown of colostomy, partial colectomy, removal of mesh prosthesis, primary repair of residual parastomal hernia defect, re -siting of end colostomy to luq (separate site).Explant date: on (b)(6) 2022 [hospitalization on (b)(6) 2022].On (b)(6) 2022 [medical records state date of surgery on (b)(6) 2022, however specimens sent to pathology were collected on (b)(6) 2022 and op note header dated on (b)(6) 2022.]: (b)(6) md.Operative report.Assistant #1: (b)(6) md ¿ resident.Assistant #2: (b)(6)¿ resident.Preoperative diagnosis: recurrent parastomal hernia.Postoperative diagnosis: same, extensive intraabdominal adhesions, parastomal mesh erosion into medial wall of colostomy, contaminated mesh prosthesis.Anesthesia: general.Estimated blood loss: 200 ml.Specimens: complications: none.Wound classification: not provided.Procedure: ¿the patient was brought to the operating room and placed in the supine position on the operating room table.After adequate general anesthesia had been induced the patient was intubated and mechanically ventilated.No foley catheter was placed in the bladder initially.No orogastric tube was placed in the stomach due to the patient's history of gastric bypass.The patient received a single dose of broad-spectrum antibiotics prior to incision.The patient's left arm was tucked low at his side and the table was flexed in order to improve trocar spacing along the left abdomen.The colostomy site was prepared by suturing the skin closed with a 2-0 vicryl.His abdomen was propped and draped in standard surgical fashion.The stoma was covered with a laparoscopic sponge and a tegaderm.A safety pause was performed.I then used a veress needle entrance technique in the luq to induce pneumoperitoneum to a pressure of 15 mmhg with carbon dioxide.This was successful on the first pass of the needle as indicated by low opening pressures and co2 insufflation rates of 2 l/min.Once pneumoperitoneum had been safely established an 8-mm trocar was placed blindly in the left lateral abdomen through a preexisting scar.The 8-mm 30-degree angled laparoscope was then inserted and the abdomen was briefly explored.There was no evidence of veress needle entrance injury.The initial trocar had entered superficially into the omentum of the luq.No bleeding was encountered and the site was later examined for deeper injury which was not identified.Diffuse and extensive adhesions were noted within the abdomen.We had entered into a small relatively adhesion free pocket in the luq, but working space was very limited.The veress needle was removed under direct vision.Multiple additional trocars were then placed sequentially including an 8-mm trocar in the lateral left abdomen and a long 8-mm trocar in the llq.Prior to placing the third trocar, we had to lyse adhesions between the abdominal wall, omentum and small bowel using laparoscopic metzenbaum shears.We could not place our robotic instruments until we achieved adequate intraabdominal space.Once i was satisfied with spacing, the robot was brought to the bedside and the arms were docked in place.Initial instruments used in this case included camera in arm #3, fenestrated bipolar in arm #2, and robotic scissor in arm #4.Arm #1 remained stowed for the entirety of the case.Careful and meticulous adhesiolysis was then performed using the da vinci xi robotic system.Diffuse involvement of the small bowel was noted.I concentrated on only the anterior adhesions, in order to obtain exposure to the region of the stoma and to gain abdominal wall space for anticipated mesh placement.This portion of the adhesiolysis alone took 3 hrs.I was able to identify the previously place [sic] synecor mesh along the abdominal wall.This appeared to be intact.Omentum was adherent to the lateral edge of the mesh.This peeled down easily with a sweeping technique.As i approached the central portion of the mesh, known to contain the stomal bowel, the adhesions became dense and vascular.I could no longer sweep these off.I could visualize the colon rising up to the mesh from the back of the abdomen, but i could not distinguish any planes between the colon edge and the mesentery.I could not see any additional involved loops of bowel.I knew from the ct scan that the recurrent hernia had entered the stoma defect along the lateral side of the repair.I therefore jumped the camera amongst arms 2, 3, and 4 to try and dissect along the lateral portion of the repair.I could visualize the synecor lateral to the colostomy and once again, noted no adjacent defect and no widening of the previous keyhole closure.I turned my attention back to the medial portion of the colon and started to dissect closer to the mesh/colon interface.As i gently swept the tissue here, a pocket opened, revealing granulation tissue and what appeared to be mucosa.It seemed that i had entered the wall of the colon.On further inspection, i noted that the edge of the synecor mesh was indeed intracolonic and had eroded into the lumen of the colon.The inner few mm's of the mesh was brown and discolored.Given this finding, i decided to convert to an open procedure and alerted the nursing and anesthesia teams.Prior to conversion, i had the bedside assist resident cut the temporary closing sutures on the colostomy and insert her finger.I could visualize her gloved finger from the robotic console, confirming that there was indeed an erosion into the colostomy at this point.The robot was then undocked and backed away from the field.The robotic trocars were removed and tegaderm dressings were placed over the incision sites.A foley catheter was placed in the bladder.The abdomen was re-prepped and redraped.The stoma was [sic] prepped into the field at this point.A dose of cefoxitin was also administered.A long laparotomy incision was then made, encompassing the prior upper and lower midline incisions.The abdomen was entered through the midline fascia overlying an area where adhesiolysis had already been performed.We once again noted diffuse, extensive interloop and pelvic adhesions to each and every loop of small bowel.The colon was located posteriorly and laterally, so was less involved in the adhesive process.I meticulously began lysing adhesions, as at this point, i couldn't even identify the origin of the colostomy or any other anatomy relating to the patient's prior gastric bypass.Sharp adhesiolysis was then performed, primarily with metzenbaum scissors and occasionally the bovie pencil.This portion of adhesiolysis took approximately another 3-4 hours.No serosal injuries or enterotomies were identified during this painstaking process.Following adhesiolysis, we were able to identify the roux limb, distal anastomosis, transverse colon, cecum and the descending colon, which traversed the abdomen to the right side to form the colostomy.We then divided the colostomy just beneath the fascia with the large enseal device.This portion of the colon was thickened and fibrotic, most likely secondary to the mesh erosion process.We then dissected out the mesentery to this portion of colon and took the omentum off of the medial aspect (anatomical).Once we had freed up the distal 6 cm's or so of colon, we assessed the perfusion of it.The entire mesentery of the original colostomy had been salvaged with the exception of the section that had been divided with the enseal.Given the thickening of the distal portion of the colon, we decided to resect a segment to get back to normal appearing bowel wall.This was performed with the gia 75mm stapler and a blue load.The colon was now ready to be brought up as a stoma once we had re-sited the new location.We then resected the entire piece of synecor mesh off of the abdominal wall using electrocautery.No tacks had been used previously but the mesh was very well incorporated, making this exercise challenging.We took care to maintain as much fascia as possible during this process.Once the mesh had been excised, we excised the entire transabdominal portion of the colostomy using electrocautery.Dissection was performed from either side of the abdominal wall.The resulting fascial defect, representing the stoma defect and subsequent hernia site, was closed with several interrupted #0 pds sutures along the posterior rectus sheath.As a result of the hernia and the trauma from the mesh excision, this tissue was not very healthy looking.As such, we planned to close the anterior fascial layer later in the case.At this point we chose an alternate site for our new stoma in the luq.A paddle of skin was removed with the bovie pencil along with a plug of subcutaneous fat.The anterior fascia was identified and incised vertically.The rectus muscle was identified and spread along its fibers to reveal the posterior sheath.The sheath was incised to allow insertion of two fingers and the descending colon was delivered through the wound to the skin.It appeared well perfused and was not under any tension whatsoever.Hemostasis was then assured.Small rents in the residual omentum were closed with interrupted 2-0 vicryl sutures.The omentum was positioned beneath the midline.The anterior fascia was identified and dissected off of the overlying subcutaneous tissues using cautery.We closed the midline with two running sutures of non-looped #0 pds.Fascia quality was good in some places and poor in others, but closure was tension free for the most part.I then created a 10 cm vertical ellipse around the 4cm wide colostomy site.This was carried down through the subcutaneous tissue, which appeared healthy.What i could identify as anterior fascia and rectus muscle was then reapproximated with a running #0 pds suture.The skin of the midline and stomal incisions was then closed with skin clips with telfa wicks in between.The robotic incisions were closed with skin clips.The colostomy was then matured at the level of the skin after protecting the other incisions and opening the colonic staple line.3-0 vicryl sutures were used to suture the colon wall to the dermis circumferentially.The stoma was not brooked.Opsite dressings were used on the incisions.A colostomy appliance was added.The patient was allowed to awaken from anesthesia and extubated without difficulty in the operating room.The patient was transported to the recovery room in stable condition where he will make his early postoperative recovery.I was physically present in the operating room for all portions of this case.Total case time was 9 hours.Total time of adhesiolysis was approximately 6-7 hrs.¿ on (b)(6) 2022: (b)(6) center.Pathology report: preop diagnosis: hernia due to colostomy.Specimen information: 1: type: tissue.Source: large intestine, nos.Collected by: (b)(6) md on (b)(6) 2022 2010.2: type: tissue.Source: other.Collected by: (b)(6) md on (b)(6) 2022 2039.3: type: tissue.Source: large intestine, nos.Collected by: (b)(6) md on (b)(6) 2022 2109.Tissue exam: final diagnosis: specimen #1 ¿ colon (descending stoma), colostomy: portion of colon with marked subserosal acute inflammation, fibrosis and focal ischemic changes of muscularis propria.Specimen #2 ¿ foreign mess [sic], eroded mesh: consistent with a mesh; see gross description.Specimen #3 ¿ colon (left), colostomy: portion of colon with ischemic mucosal necrosis.Fragments of fibromembranous tissue and mature adipose tissue with mild chronic inflammation.Gross description: 1.Large intestine, nos: the specimen is received in formalin, labeled with the patient¿s name, medical record number, date of birth, and ¿descending colon stoma.¿ the specimen consists of a 55 cm in length, by 2.7 cm in diameter portion of bowel.There is a 3.2 x 2.4 cm pink mucosal defect at 1 end, and the opposing stapled margin is inked black.The specimen is opened revealing the mucosal defect communicates directly with underlying bowel.The mucosa is tan -pink with prominent folds.The bowel wall is 0.5 cm in thickness.Representative sections are submitted as follows: 1a: bowel margin, en face.1b: mucosal defect, and underlying bowel wall.2.Other: the specimen is received in formalin, labeled with the patient's name, medical record number, date of birth, and ¿eroded mesh¿.The specimen consists of 15 x 8.3 x 0.4 cm elongate pink-white portion of fabric consistent with a mech.The specimen is for gross examination only.A photograph is taken.No sections are submitted.3.Large intestine, nos: the specimen is received in formalin, labeled with the patient¿s name, medical record number, date of birth, and colostomy, li colon¿ [sic].The specimen consists of a 12 cm in length, by 4.5 cm in average circumference fragmented portion of bowel, surfaced by 3.5 cm in diameter pink mucosal defect communicating with the lumen.The possible bowel margin is inked black.The mucosa is tan with prominent folds, and the bowel wall averages 0.7 cm in thickness.The bowel portion is attached to a 14 x 9.7 x 4.6 cm saccular pink-yellow membranous tissue, with fibrofatty regions.The membranous tissue averages 0.1 cm in thickness, and has a smooth pink surface.Representative sections are submitted as follows.3a.Bowel margin, en face.3b: mucosal detect, and underlying bowel wall.3c: saccular, membranous tissue portion.A potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information.It should be noted that the gore® synecor intraperitoneal biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: conclusion code remains unchanged.It should be noted that the gore® synecor® intraperitoneal biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer Narrative
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H6: updated health effect h6: updated investigation finding h6: updated type of investigation h6: updated investigation conclusions.The investigation has been completed.Based upon the totality of the information received over the course of the investigation and reported by gore in the previously submitted medical record narratives the following conclusions have been reached.As previously reported, all pertinent medical records requested may not have been received.In the absence of additional information or medical records from the complainant, this event file will be closed with the information provided.It should be noted that the gore® synecor intraperitoneal biomaterial instructions for use include warnings and addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, adhesions and related harms, bowel obstruction, contamination, defect recurrence and related harms, dysphagia, erosion or extrusions and related harms, exposure or protrusions and related harms, fever, fistula, gerd recurrence, infection, irritation or inflammation, mesh migration, mesh shrinkage, pain, parathesis, seroma or hematoma and related harms, tissue ischemia, wound dehiscence and additional intervention including surgery.¿ the instructions for use further state: ¿use of absorbable sutures to secure the mesh in place may result in inadequate fixation.Ensure staple size and staple or tack spacing provides adequate fixation of device to tissue.Insufficient fixation of the device may result in mesh migration, erosion or extrusion, hernia recurrence, or recurrence of soft tissue deficiency which may lead to bowel obstruction, dysphagia, fistula, gerd recurrence, pain, and additional intervention including surgery.¿ individual medical decisions, if inconsistent and/or non-conforming to the device manufacturer¿s recommendations, ifu, or recognized best practices, may result in or contribute to an adverse event.Medical records that indicate mesh exposure may reflect abdominal wall wound dehiscence as a function of a patient¿s poor tissue quality or loss of anchorage of fixation or may be related to individual patient comorbidities, and technical and/or procedural aspects of the repair.These factors include, but are not limited to, fixation type, suture technique, type of and tension on the incision, and wound classification at time of procedure.Post-operative factors such as the development of a post-operative infection, an incision and drainage procedure, or wound packing could result in mesh exposure.Additionally, patient comorbidities that could influence wound dehiscence leading to mesh exposure include, but are not limited to, smoking and obesity.As with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without mesh.These may include but are not limited to, adhesions and related harms, bleeding, bowel obstruction, compromised device biocompatibility, contamination which may lead to patient harms, device damage, dysphagia, erosion or extrusion and related harms, exposure or protrusion and related harms, fever, fistula, gerd recurrence, defect recurrence and related harms, ileus, increased procedure time and related harms, irritation or inflammation, infection, mesh migration, mesh contraction, pain, paresthesia, perforation, revision/re-intervention, seroma or hematoma and related harms, tissue ischemia, wound complications and wound dehiscence and additional intervention including surgery.Many of the potential complications are associated with the patient¿s underlying disease progression, co-morbidities, additional medical history and/or other surgical procedures.The above inherent risks are typically detailed in standard informed consent documents.The device was not able to be returned to gore for evaluation; therefore, a direct product analysis could not be conducted.Review of the manufacturing records verified that the lot met all pre-release specifications.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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