|
W. L. GORE & ASSOCIATES, INC. GORE® BIO-A® TISSUE REINFORCEMENT; MESH, SURGICAL, POLYMERIC
|
Back to Search Results |
|
| Catalog Number FS0915 |
| Device Problem
Insufficient Information (3190)
|
| Patient Problems
Abscess (1690); Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
|
| Event Date 03/08/2013 |
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
It should be noted that the gore¿ bio-a¿ tissue reinforcement 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¿ bio-a¿ tissue reinforcement 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.".
|
| |
|
Event Description
|
|
It was reported to gore that the patient underwent open incisional hernia repair on (b)(6) 2012 whereby a gore¿ dualmesh¿ plus biomaterial was implanted and on (b)(6) 2013 whereby a gore¿ bio-a¿ tissue reinforcement was implanted.The complaint alleges that on (b)(6) 2013 and (b)(6) 2018, additional procedures occurred whereby a gore device was explanted.It was reported the patient alleges the following injuries: infection, recurrence, removal of mesh, abscesses, severe and chronic pain/discomfort.Additional event specific information was not provided.
|
| |
|
Manufacturer Narrative
|
|
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 #1: mesh repair of four recurrent incisional hernias, excision of old abdominal wall mesh.Implant: gore® dualmesh® plus biomaterial (1dlmcp04/ (b)(6), 15 x19 cm) x 2.Implant #1 date: (b)(6) 2012.(hospitalization: ni).(b)(6) 2012: (b)(6) regional healthcare system.(b)(6) md.Operative report.Indications: 53-year-old male with symptomatic recurrent incisional hernias.He does have mechanical aortic valve and is therefore dependent on systemic anticoagulation.He is taken to the operating room at this time for mesh repair of his recurrent symptomatic incisional hernias with heparin window.Preoperative diagnosis: symptomatic recurrent incisional hernias.Postoperative diagnosis: same.Anesthesia: general.Estimated blood loss: 150 ml.Findings: four recurrent incisional hernias were identified and repaired with mesh.Procedure: ¿with patient in a supine position, abdomen is prepped and draped in standard fashion.An old vertical midline incision is opened extending from below the xiphoid process to just below the umbilicus and dissection continues through skin and through copious subcutaneous adipose tissue.Four recurrent incisional hernias are noted.Fascia separating four hernias was carefully divided creating one larger hernia defect.Extensive adhesions are taken down.Particular care is taken to avoid intestinal injury.A shelf is created anterior to fascia for placement of sutures.The patient¿s morbid obesity does complicate his procedure.The hernia defect measures about 16 cm in length and about 20 cm in diameter.The largest piece of mesh on stock at (b)(6) regional today is 19 cm in length by 15 cm wide.Two pieces of this mesh are obtained and the two pieces of mesh are sutured to each other making a piece of mesh that measures approximately 20 cm in length and about 28 cm in diameter.This is a gore dualmesh prosthesis.The two pieces of mesh were sutured to each other with multiple horizontal mattress sutures of 0 gore-tex suture.One piece of mesh to the left of midline is extensively involved with omental adhesions and the mesh has contracted and folded over on itself considerably.This piece of mesh is excised in its entirety utilizing electrocautery and is sent to pathology.The dualmesh prosthesis is positioned intraperitoneally with the smooth layer facing the omentum and the corrugated layer facing anterior abdominal wall.The mesh is sutured to full thickness fascia with multiple interrupted horizontal mattress sutures of 0 gore-tex.Particular care is taken to avoid bowel injury.Upon completion of the repair, there is no tension on the repair, no further hernia defects are noted.The wound is irrigated.Attenuated fascia is closed anterior to the mesh with two running sutures of single strand #1 pds.Subcutaneous tissues irrigated and then closed with running 2-0 vicryls suture.The skin is closed with skin staples.Dermabond ointment applied to the staples.Dry dressing applied.Sponge, instrument, and needle counts reported as correct.¿ drains: none.Complications: none.(b)(6) 2012: (b)(6) regional healthcare system.Implant record.Implant/ explant info: incisional ventral hernia rep mesh.Description: mesh, dual plus 15 x 19 (6x6).Type: implant.Qty: 2.Expiration: 9/2014.Lot#: 9907996.Model#: 1dlmcp04.Site: abdomen.Mfg: w.L.Gore & associates.The records confirm a gore® dualmesh® plus biomaterial (1dlmcp04/ (b)(6)) was implanted during the procedure.[quantity of 2].Explant #1/ implant #2 procedure: removal of infected abdominal wall mesh, mesh repair of recurrent incisional hernia, incision and drainage of abdominal abscess, scalpel excisional sharp debridement of stage iii abdominal wound with removal of nonviable skin, subcutaneous tissue, fascia and muscle for 300 square cm, wound vac application.Implant: gore® bio-a® tissue reinforcement (fs0915/ (b)(6) , 9 x 15 cm).Explant #1/ implant #2 date: (b)(6) 2013 (hospitalization ni).(b)(6) 2013: (b)(6) regional healthcare system.(b)(6) md.Operative report.Indications: 54-year-old male with an infected abdominal wall mesh utilized for repair of incisional hernia in the past.Patient was in an automobile accident sustaining a large abdominal wall hematoma that required surgical drainage.I believe the hematoma likely became secondarily infected and now has an infected his mesh.He is taken to the operating room at this time for removal of this infected mesh and then repair of the recurrent incisional hernia with absorbable mesh.Abdominal wall infection will be drained debrided.Preoperative diagnosis: infected abdominal wall mesh, abdominal wall abscess and infection.Postoperative diagnosis: infected abdominal wall mesh, abdominal wall abscess and infection.Anesthesia: general.Estimated blood loss: 150 ml.Findings: infected dualmesh was noted and removed.An abdominal wall abscess was drained.Nonviable abdominal wall tissues were debrided.The resultant recurrent incisional hernia was repaired with absorbable mesh given the abdominal wall infection.Wound vac was applied.Procedure: ¿with patient in a supine position, abdomen is prepped and draped in a standard fashion.His old vertical midline incision is opened and dissection carried through skin and subcutaneous tissues.A large amount of scar is noted.Towards the upper portion of the incision abscess cavity is entered measuring about 6 cm in diameter and this does seem to track down to or least very close to his chronic abdominal wall mesh.The abscess was drained and aerobic and anaerobic cultures were obtained.The old mesh is exposed.The corrugated layer of large piece of dualmesh is noted.The anterior aspect of the prosthesis is exposed throughout its length.This appears to be two pieces of dualmesh were sutured together in the center.Multiple interrupted horizontal mattress sutures of 0 gore-tex were noted, securing the mesh to full thickness fascia.The gore-tex sutures are divided and removed and the deep surface of the mesh is exposed.The abdomen has reperitonealized and the old mesh was removed in its entirety without entering the true peritoneal space.A large amount of fluid is present around the mesh consistent with infection and though this fluid around the mesh was not purulent, but rather serosanguineous.The mesh was removed it its entirety and sent to pathology.Divided sutures are removed.The wound is irrigated.The defect created by removing the mesh is measured and a bio-a absorbable hernia prosthetic mesh is obtained and this is positioned in the space that previously held the ptfe mesh.A 15 x 9 piece of gore bio-a absorbable mesh was placed in the hernia defect deep to fascia and this mesh is sutured to fascia circumferentially with multiple interrupted horizontal mattress sutures of 0 vicryl.Attenuated fascia was then closed anterior to this absorbable mesh with multiple interrupted #1 pds sutures.Absorbable sutures were used for this layer given the active abdominal wall infection and the desire to avoid permanent sutures that could be a nidus for bowel injury throughout the operation.Ture peritoneal space was not entered and bowel was not visualized.The wound vac negative pressure dressing was applied.The black sponge is cut to fit the open abdominal wall defect and sponge was applied to the defect.Skin and subcutaneous tissues are left and a one cm diameter perforation was cut in this airtight covering and this is attached to the wound vac suction device.Suction is applied and there is good collapse of the sponge with no significant air leak noted.Patient was taken to the recovery room in satisfactory condition.¿ drains: one wound vac.Complications: none.Sponge, instrument, and needle counts reported as correct.(b)(6) 2013: (b)(6) regional healthcare system.Implant record.Implant/explant: incisional ventral hernia rep mesh.Description: bio-a-mesh 9mx15 fs0915.Qty: 1.Expiration: 8/2015.Lot#: 1072284.Model# fs0915.Site: incisional hernia.Mfg: w.L.Gore & associates.(b)(6) 2013: (b)(6) regional healthcare system.Nurse notes.Wound classification: contaminated.The records confirm a gore® bio-a® tissue reinforcement (fs0915/ (b)(6)) was implanted during the procedure.Relevant medical information: (b)(6) 2015: (b)(6) regional medical center.(b)(6) md.First assistant: (b)(6) md/ hs.Procedure: open repair of recurrent ventral incisional hernia with bilateral component separation and mesh implantation.Indications for procedure: the patient is a 56-year-old man who has had multiple abdominal operations in the past, including hernia repairs.He has multiple medical problems including history of deep venous thrombosis.He presents with an enlarging recurrent incisional hernia which incorporates the majority of his abdominal wall.He has morbid obesity, but has recently lost nearly 70 pounds in preparation for the operation.A ct scan confirms the anatomy with significant separation of his lower rectus muscles.The risks, benefits, and alternatives to this extensive procedure were explained in detail to the patient and his family members.They expressed understanding and would like to proceed.Description of procedure: ¿the patient was brought to the operating room, placed in a supine position.A general anesthetic was administered.A foley catheter was placed.His abdomen was prepped and draped in the usual sterile fashion.A vertical midline incision was made, incorporating the majority of the anterior abdominal wall.An extensive meticulous dissection was then undertaken separating out the scar tissue and hernia sac from the subcutaneous tissues circumferentially to the anterior recuts sheath which lay separated on both sides.There was a large amount of scar tissue, and fibrous connective tissue, and eventually this was all excised laterally to the medial border of each of the rectus sheaths.Lysis of adhesions was performed in a limited fashion, only enough to close the midline together.There were multiple loculations of the hernia sac.The fascial edges were then brought to the midline in a vertical fashion with interrupted figure-of-eight #1 prolene sutures.There was some tension especially to the middle of the repair and therefore a bilateral component separation was performed by incising the most lateral portion of the anterior recuts sheath on the left, and the medial most portion of the external oblique aponeurosis on the right.This extended nearly the entire length of the midline fascial repair and released the tension on the midline suture line.A 12 x 12 inch piece of ultrapro mesh was brought up into the field.It was placed in an onlay technique over the entire abdominal wall.The lateral portions of the mesh reached the lateral cut edge of the component separations on both sides.Superiorly, the mesh completely covered the midline suture line and extended 5 cm above nearly to the xiphoid.Inferiorly it was extended past the suture line and nearly went to the pubis.The mesh ended up to be probably 10-11 inches in diameter.It was cut to fit.It was sewn into place with running 0 prolene circumferentially.Another suture line was placed between the mesh and the medial cut edge of the component separation on both sides.Generous irrigation was performed.Hemostasis was obtained with cautery.Two drains were then placed, one exiting on both lower quadrants through a separate stab wound and secured to the skin with a 3-0 nylon.Both drains were held in place on the mesh with a small chronic suture.The subcutaneous tissues were then closed with interrupted 3-0 vicryl and skin was closed with clips.Sterile dressing was applied.The patient tolerated the procedure well.He was withdrawn from general anesthesia, extubated and brought to recovery in good condition.¿ (b)(6) 2015: (b)(6) regional medical center.Implant sticker.Ethicon® ultrapro [illegible].[handwritten]: dr.(b)(6).Open repair ventral incisional hernia w/ synthetic mesh, component separation.(b)(6) 2015: (b)(6) regional medical center.Implant record.Abdomen.Mesh ultrapro 30x30 cm.Implant type: mesh.Implanted area: abdomen.Number implanted: 1.Lot number: hk8hglw0.(b)(6) 2018: (b)(6) regional healthcare system.(b)(6) md.Operative report.Pre-op dx: recurrent incarcerated incisional hernia.Post-op dx: same.Surgeon: (b)(6).Procedure: robotic-assisted repair of incisional hernia with prosthetic material.Anesthesia: geta.Ebl 5 ml.Indication: patient presents with a recurrent incisional hernia which is incarcerated.Patient agreed undergo robotic- assisted repair and gave informed consent.Procedure summary: patient was brought to the operating room after receiving preoperative iv antibiotics and with scds on the lower extremities.The patient was placed under general endotracheal anesthesia.A foley catheter was inserted into the urinary bladder under sterile technique and was removed at conclusion of the case.The abdomen was prepped and draped standard fashion.A 2 cm incision was made lateral aspect of the abdomen.The fascia of the anterior abdominal wall was grasped and elevated with penetrating towel clips.A 12 mm optiview trocar was utilized with a 0° laparoscope to insert the trocar under direct vision through the abdominal wall and into the abdominal cavity.A pneumoperitoneum was then created with co2 gas maintaining a pressure 15 cm mercury.The pressure was decreased to 8 mmhg during closure hernia defect and also during suturing of the mesh in place.A 1 cm incision was made in the left upper quadrant abdomen through which an 12 mm trocar was then inserted.An 8 mm trochar was inserted within this trochar allowing easy removal and replacement during insertion and retrieval of sutures and mesh.A 3rd 1 cm incision in the left lower quadrant abdomen through which a 8 mm trocar was inserted.The contents of the hernia were returned to the abdomen lysing adhesions with electrocautery.To help retract the contents of the incarcerated hernia a 5 mm trocar was inserted through one similar incision in the upper left portion of the abdomen.This allowed use of another grasper to help retract the incarcerated contents.The peritoneum around the hernia defect was opened exposing the fascia.The fascial defect was closed with a nonabsorbable 0 v-block suture.Ventral light st mesh 8 inches in greatest length was utilized for the repair.The nonabsorbable suture was used to hold the mesh in place.The insufflation device was pulled out through the skin surface anteriorly and then used to inflate the latter structure under the mesh to hold it in place.The mesh was then sutured in place with a 0 v-block suture in a running fashion circumferentially.When this was completed the needle was removed from the abdomen as well as the insufflation portion of the support device.The mesh was noted to be in good position pneumoperitoneum was released after the instruments and trochars were all removed under direct vision.The 12 mm trochar site was closed at the fascial layer with a 0 pds suture.The skin edges at the incision sites were closed with 4-0 monocryl in a subcuticular fashion.The patient was awakened and extubated and brought to the recovery room in stable condition.¿ condition upon transfer: [checked] stable.Transferred to: [checked] recovery room.(b)(6) 2018: (b)(6) regional healthcare system.Implant record.Size: 6¿x8¿.Expiration: 11/2019.Site: ventral hernia.Lot#: hubv0542.Model#: 5955660.Mfg: bard parker.(b)(6) 2018: (b)(6) regional healthcare system.Nurse notes.Wound classification: clean.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® bio-a® tissue reinforcement 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® bio-a® tissue reinforcement 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.
|
| |
|
Manufacturer Narrative
|
|
It should be noted that the gore® bio-a® tissue reinforcement 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® bio-a® tissue reinforcement 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 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.
|
| |
|
Manufacturer Narrative
|
|
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.Through gore's investigation and based on the available information there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.Therefore, this event is being coded as no clinical signs, symptoms or conditions, no health consequences or impact and will be closed as no problem detected.Previous patient codes were reported based on the original complaint and are no longer applicable and/or not reportable per gore¿s investigation.Following gore¿s investigation, the previously submitted annex f code has been updated to reflect gore¿s final conclusion.The instructions for use states: ¿the implanted gore® bio-a® tissue reinforcement is a porous fibrous structure composed solely of synthetic bioabsorbable poly(glycolide: trimethylene carbonate) copolymer.Degraded via a combination of hydrolytic and enzymatic pathways, the copolymer has been found to be both biocompatible and nonantigenic.In vivo studies with this copolymer indicate the bioabsorption process should be complete by six to seven months.¿ as with any surgical procedure, there are always risks of complications for surgical repair of hernias and soft tissue deficiencies, with or without bio-a.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, migration, 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.Based upon the information received, the device was not available for evaluation.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.
|
| |
|
Search Alerts/Recalls
|
|
|
