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W. L. GORE & ASSOCIATES, INC. GORE® SYNECOR® INTRAPERITONEAL BIOMATERIAL; MESH, SURGICAL, POLYMERIC
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| Model Number GKFR2030 |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Erosion (1750); Unspecified Infection (1930); Tissue Breakdown (2681)
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| Event Date 05/29/2020 |
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Event Type
Injury
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Manufacturer Narrative
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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." the gore® synecor intraperitoneal biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.".
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Event Description
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It was reported to gore that the patient underwent open incisional hernia repair on (b)(6) 2019 whereby a gore® synecor intraperitoneal biomaterial was implanted.The complaint alleges that on (b)(6) 2020, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: infection.Additional event specific information was not provided.
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Manufacturer Narrative
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B7: added medical history.H6: conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant procedure: recurrent incisional hernia repair, reducible midline with mesh insertion.Implant: gore® synecor intraperitoneal biomaterial [gkfr2030/16486558, 20 cm x 30 cm] implant date: on (b)(6) 2019 (hospitalization [ni]).On (b)(6) 2019: (b)(6), md.Operative report.Preoperative diagnosis: incisional hernia.Incisional, without obstruction or gangrene, recurrent.Postoperative diagnosis: incisional hernia.Incisional without obstruction or gangrene, recurrent.Anesthesia: general.Estimated blood loss: 50 cc.Findings: multiple hernia defects, all up and down the old incision, all combined into one large hernia which required a 20 x 30 cm sheet of synecor for definitive repair.Specimen removed: none sent.Complications: no complications.Indications: this is a 55-year-old gentleman who has had a previous incisional hernia repair.It has not recurred.He is undergoing repair of his current incisional hernia.Technique: ¿the patient was taken to the operating room, placed in a supine position, and given successful general endotracheal anesthesia.He was then prepped and draped in the usual sterile fashion about the entire abdomen.A skin incision was then made overlying the known hernia defect and carried through the subcutaneous tissues to the level of the hernia sac which was then incised with metzenbaum scissors.The hernia sac was then entered.This was then opened further.Adhesions were identified.These were then taken down using both blunt and sharp dissection.As we went up and down the incision, we kept finding hernia defects from the top of the incision down to the bottom of the incision so the entire incision had to be reopened.These hernia defects were connected into one large defect by excising the intervening bridges of fascia.We then freed up all adhesions on the posterior surface of the fascia.The anterior fascia was also prepared for implantation of the mesh by raising up skin flaps.This was a 10 x 20 cm defect requiring a 20 x 30 cm sheet of synecor to achieve a 5 cm overlap circumferentially.This was then put in place with interrupted sutures of #1 prolene in a u stitch fashion circumferentially.This was able to be repaired without any tension.We were also able to partially close the inferior fascia with a running suture of #1 prolene for approximately the distal 10 cm of the wound.The operative field was then copiously irrigated with saline solution.Inspection revealed hemostasis to be achieved.Gentamicin was instilled onto the mesh.Two large flat jp drains were placed through separate stab incisions bilaterally inferiorly and secured to the skin with single sutures of 2-0 silk.The umbilicus was tacked to the underlying fascia with a single suture of #1 prolene.The subcutaneous tissues were closed with a running suture of 0 vicryl.The skin was further closed with staples.Dry sterile dressings were then applied.¿ on (b)(6) 2019: (b)(6) center.Implant sticker.Gore® synecor intraperitoneal biomaterial.Ref: gkfr2030.Sn: (b)(6).Expiration: 2020-05-08.[sticker with barcode]: [illegible] synecor bi #71350.Material 20 cm x 30 cm.The records confirm a gore® synecor intraperitoneal biomaterial (gkfr2030/(b)(6) was implanted during the procedure.Relevant medical information: on (b)(6) 2019: (b)(6), do.Operative report.Preoperative diagnosis: open wound of abdominal wall.Abdominal wall without penetration into peritoneal cavity; periumbilical region.Postoperative diagnosis: open wound of abdominal wall.Abdominal wall without penetration into peritoneal cavity; periumbilical region.Excisional debridement midline.Placement of wound vacuum; surface area greater than 50 square centimeters midline.Assistants: none.Anesthesia: per anesthesia record.Estimated blood loss: per anesthesia record.Findings: see post-operative diagnoses.Specimen removed: none.Complications: no complications were noted.Indications: the patient is an extremely pleasant 55-year-old male patient in with a chief complaint of an open wound of the abdominal wall.He underwent ventral herniorrhaphy with mesh placement.He had an opening of the wound, and the wound now has a small dehiscence with an open wound approximately 10 cm x 10 cm.He is in today for debridement and placement of a wound vac.Technique: ¿following appropriate permit and consent, the patient was taken into the operating room, was placed on the operating room table in the supine position, and was prepped and draped in the usual sterile fashion utilizing betadine solution and sterile drapes.Following appropriate anesthesia, a #10 blade scalpel was used and a sharp mechanical excisional debridement was then undertaken down through the skin into the subcutaneous tissues encircling the open area.Bovie cautery was then used and the incision was deepened down to the level of the subcutaneous tissues.Good hemostasis was appreciated.All nonviable tissue was removed.At which point, then the granufoam was cut to the appropriate size and shape and placed within the wound bed.The occlusive dressing was then placed on top of the granufoam.At which point, then the connector tubing was then attached as well.The tubing was then hooked to the wound vac which reveled no leaks.The patient was then sent from the or with the wound vac settings a 125 mmhg and moderate intensity.The patient tolerated the procedure well.There were no complications to the above procedure.With all sponge and needle counts being correct x2, the patient was transported to recovery.See above.¿ disposition: the patient tolerated the procedure well without any complications and was transferred to recovery.Explant procedure: open explanation of infected prosthetic mesh.Recurrent incisional hernia repair.Bilateral myofascial component separation.Implantation of biosynthetic mesh.Lysis of adhesion for 30 minutes.Excision of skin and soft tissue of 22 x 10 cm.Explant date: on (b)(6) 2020 (hospitalization on (b)(6) 2020).On (b)(6) 2020: (b)(6), md.Operative report.Preoperative diagnosis: infected abdominal wall mesh.Recurrent incisional hernia.Postoperative diagnosis: infected abdominal wall mesh.Recurrent incisional hernia.Assistant surgeon: (b)(6), do.Anesthesia: general.Estimated blood loss: 150 ml.Complications: none.Specimens: explanted hernia mesh with eroded skin.Drains: 19-french blake drain.One in the sublay position marked by prolene stitch.Next one in the subcutaneous position marked by nylon.Wound classification: iii.Indications for procedure: this is a gentleman who had a previous exploratory laparotomy developed a hernia, underwent a laparoscopic hernia repair with ipom then eventration of his product which eroded and ulcerated through his skin.He had exposed infected mesh, was on the iv antibiotics at home as well as multiple pieces of mesh excised at the bedside.He now met preoperative optimization, including nonsmoking, nondiabetic, weight improvement as well as a preoperative ivc filter secondary to a prior history of dvt, pe and the need for anticoagulation.The patient did preoperative optimization, including impact ar, gatorade and holding his coumadin.Findings: the patient had a 20 x 20 cm of mesh that was explanted with a skin paddle.This was densely adherent to the underlying small bowel as there had been epithelialization of the mesh onto the small bowel.This required extreme lysis of adhesions.I then had to reconstruct a greater than 10 cm defect, which was done with bilateral transverses abdominis myofascial component separation and implantation of a 40 cm tall x 35 cm phasix mesh.We did have primary approximation.However, there was some tension around the subcostal portion as there was limited music overlap in this position.Description of procedure: ¿patient identified in the preoperative holding area by 2 identifiers, taken to the operating room and placed in supine position on the operative table after appropriate hemodynamic monitors were placed and its induction of endotracheal anesthesia.Foley catheter was placed.The abdomen was clipped free of hair.Bilateral tap blocks were then performed.The abdomen was then prepped and draped in standard sterile fashion.A timeout was performed.I imbricated all of his excess soft tissue to the edge of the palpable hernia sac and marked an elliptical incision around his prior epithelialized area of mesh, old scar and excess soft tissue.We then excised this elliptic and using a 10 blade scalpel, carried down through subcutaneous tissue using electrocautery.In doing so, i met mesh in certain locations as the mesh had been just underneath his diastasis or his ventral hernia.In order to island the area of mesh as well as the epithelization at the skin level i did have to work for the next 2 hours in a combination of lysis of adhesion and mesh explanation to dissect the mesh from the peritoneal surface, preserving the posterior sheath under the rectus muscles both left and right, as well as dissecting it off of the underlying viscera including omentum, colon and small bowel.Every piece of prolene suture as well as every piece of the 20 x 20 cm mesh was excised.As i was able to island this, it was evident that there were 2 separate loops of small bowel that were going up to the area of epithelialization underneath the mesh.At this area, sharp lysis of adhesion using a 10 blade scalpel was performed and the mesh was then removed.There were 2 small serosal tears on the small bowel, which were imbricated using 3-0 vicryl.There was no need for small-bowel resection or full thickness injury to the viscera.We then irrigated the abdomen clean.There was no evidence of additional off screen bleeding or issues.A blue towel was then placed over the viscera and we started working on out lateral dissections.There was some remaining old hernia sac, which had been preserved.This was in line with the posterior sheath.We continued our dissection with the hernia sac laterally, identifying the anterior fascia, incising the anterior fascia overlying the left rectus muscle, sweeping the rectus muscle superolaterally and keeping the hernia sac in line with my posterior sheath.I did my standard retrorectus dissection on the left side from cranial to causally from the xiphoid to the pubis.Please note that the mid portion of the abdomen the muscle itself was thin and watery and the fascia in this location was also thin on the anterior section.I dissected all the way lateral to the neurovascular bundles sacrificing only 1 neurovascular bundle on the left-hand side secondary to a close approximation from a prior suture tract that was scared in.We then turned-out attention to the left hand side, repeated the exact same thing dissecting the hernia sac off the anterior fascia, identifying the anterior fascia, incising it, sweeping the muscle superolaterally, keeping the hernia sac in line with the posterior sheath.Following this, a subxiphoid dissection was performed dropping the falciform and the preperitoneal fat pad beneath the xiphoid identifying the diaphragmatic fibers.Inferiorly, we dissected into the space of retzius.We were able to cross the midline, and dissected into the space of retzius.We were able to cross the midline, and dissect all the way down to the level of the sheath/hernia sac.We did have small areas of hernia sac, which we were able to excise secondary to excess and thin ratty nature.We then started our myofascial component separation starting on the left had side, incising the transverse abdominis muscle 1 cm medial to the neurovascular bundles using electrocautery.After incising the anterior portion of it using a right angle with elevation the muscles were transected, keeping the posterior transversalis fascia in line with the posterior sheath.This was then performed all the way down in a segmented nature.I was able to sweep the transversalis fibers laterally all the way 3 cm beneath the subcoastal margin laterally all the way to the psoas muscle in the mid axillary line.At the inferior portion where the transversalis abdominis fibers thinned out i had used a 10 blade scalpel in order to get the transversalis fascia at the level of the arcuate line.Please note that there was on section on the left had side, no more than 2 cm in size, which due to scarring i had jumped up into the semilunaris line.I immediately noted this, corrected it, incised beneath it and closed that defect in the semilunaris line with vicryl suture.Please note that the entire semilunaris on both left and right would appropriately covered with my sublay mesh.I then turned my attention over the right hand side.In the exact same fashion we incised the transverse abdominis fibers 1 cm medial to the neurovascular bundles, transected all the transversalis muscle fibers, swept them superolaterally to keep the posterior transversalis fascia in line with the posterior sheath.Again, at approximately t11-12 this area became much thinner, required a 10 blade scalpel for completion to the arcuate line.I was able to get a lateral dissection all the way to the mid axillary line.Bilateral inguinal canals were identified, but no evidence of inguinal hernia.We then closed the posterior sheath in a running fashion using 2-0 vicryl suture.The entire sublay position was irrigated with saline, with no evidence of bleeding.There was one small peritoneotomy in the right upper side, which was closed interrupted using 3-0 vicryl suture.Prior to final closure of the posterior sheath, we did reevaluate the viscera with no evidence of bleeding.Next, we brought a piece of mesh in 40 cm tall x 35 cm wide.This laid in the sublay position, anchored cranially on both sides of the xiphoid using #1 maxon sutures as well as inferiorly above the pubis using #1 maxon sutures.I used the lateral transfascial fixation on both the left and right using an 11 blade to incise the skin with a transfascial fixation using reviewed reverdin needle.Mesh laid nice and taut with good approximation of midline.A 19-french blake drain was taut with good approximation of midline.A 19-french blake drain was placed in the sublay position.Prior to the anterior fascial closure, i placed 10 ml of tisseel to help both with hemostasis and for fixation of my mesh in the short-term.We then closed the anterior fascia using interrupted figure of eight #1 maxon sutures in a progressive fashion from the bottom up.When we got to the mid abdomen, i used 2 interrupted areas in order to reapproximate and monitor my pulmonary function.He did have a peak airway pressure rise of 6 but that was at a volume of 625.He was able to recruit a tidal volume with valsalva to over 2 liters without muscle shearing so i felt comfortable with my muscle closure.We continued to progressively closed the fascia in an interrupted fashion.Around the epigastric and costal position there was a 2 x 2 cm area where there was a minimal fascia secondary to no ability to really gain any additional length or any additional release.I was able to piecemeal fascia together in this location with a large muscle bulk underneath.However, given his infected nature and the fact that i had to use a phasix mesh he will likely get a small hernia at this location pending his postoperative recovery.I did not want to put any additional products in his body given his situation and reason for this operation.I then again valsalva ed to 2 liters with no evidence of tension shearing upon my anterior fascia.Subcutaneous space was then irrigated and closed in a progressive fashion using 2-0 vicryl quilting sutures.A 19 french blake drain was placed, followed by 3-0 deep dermals and a 4-0 running v-loc in a running fashion, dressed with dermabond.The sublay drain was marked with prolene.Subcutaneous drain was marked with nylon covered with a 4 x 4 dressing.The patient tolerated the procedure well, was awakened form anesthesia, extubated without difficulty and transferred to the recovery in stable condition with a blood pressure in the 110s to 120s, nontachycardic and end tidal less than 40.The patient¿s foley catheter was left in place.I was present for the entirety of the operation.All instrument, needle, and sponge counts were correctly reported x2.¿ 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.The gore® synecor intraperitoneal biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.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 results code.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.The gore® synecor® intraperitoneal biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.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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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.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.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 warn: ¿as with any implantable surgical device, strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.¿ procedure and specific patient factors may contribute to or cause infection, leading to contamination, exposure, lack of incorporation and/or seeding of device.Procedure related factors may include adherence to clinical guidelines on infection risk management, contamination of device prior to or during implant, and post-operative persistent/symptomatic seroma and wound management.Patient risk factors may include diabetes, smoking, age, malnutrition, immunosuppressive therapy, post-operative instruction noncompliance, and hygiene.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 and sterilization 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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