MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® BIOMATERIAL; MESH, SURGICAL, POLYMERIC

Device Problem Use of Device Problem (1670)

Patient Problems Wound Dehiscence (1154); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2022

Event Type  Injury  

Manufacturer Narrative

Journal article: international journal of surgery case reports 53 (2018) 381¿385 https://doi.Org/10.1016/j.Ijscr.2018.11.028 2210-2612/© 2018 the authors.Published by elsevier ltd on behalf of ijs publishing group ltd.This is an open access article under the cc by license (http://creativecommons.Org/licenses/by/4.0/).Multiple attempts have been made to obtain additional information.As no additional information has been received from the corresponding author, this file will be closed.Per the instructions for use (ifu) for the gore® dualmesh® biomaterial usage: do not fix this product with the textured surface facing the organ side.When fixed with the textured surface facing the organ side, adhesion or seroma formation may develop.Operating instructions and method of use, etc.This product shall be fixed with the smooth side facing toward the organs, after being trimmed to a proper size and shape.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.There is insufficient information available for gore to reasonably draw conclusions related to aspects of the event.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.".

Event Description

The literature article: ¿mesh trimming and suture reconstruction for wound dehiscence after huge abdominal intercostal hernia repair: a case report¿ published by yuta takeuchi, m.D.Was reviewed.The article was published online november 22, 2018.The article reports a (b)(6)-year-old man with an incisional hernia in the left flank from just below the eight intercostal space to the transverse umbilical region 6 months after thoracoabdominal aortic aneurysm surgery.At post operative day 26, we observed mesh exposure due to wound dehiscence.Mesh trimming and suture reconstruction for wound dehiscence was performed because there were no signs of wound infection.The postoperative course was uneventful including infection and dehiscence.The patient has been well without recurrence for 14 months since last operation.On postoperative day 26, we detected that a 3 × 7 cm mesh was exposed due to wound dehiscence without infection.The patient was placed on the right semi-lateral decubitus position under general anesthesia.A 20-cm long incision was made over the hernia along the previous wound.The hernia sac was identified and opened.There was no adhesion between the hernia sac and intra-abdominal contents.We tried to secure a space to place the mesh (35 25 cm in size) in the extraperitoneal space.The mesh was expanded × polytetrafluoroethylene: gore® dualmesh® patch.The article reports 1 wound dehiscence and a partial mesh explant.

Manufacturer Narrative

Note that we a retracting the previously sent mw.This event is not reportable.It is noted in the article ¿reported comorbidities were diabetes and granulomatosis with polyangiitis treated with steroids and immunosuppressants.¿ based on md32961, ¿exposure/protrusion of device due to patient underlying conditions (e.G., wound healing issues associated with chronic steroid use or diabetes)¿ is not reportable.H6: updated health effect.H6: updated investigation finding.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.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.It should be noted that the gore® dualmesh® 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, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.¿ 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.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.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 shrinkage, 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.

Manufacturer Narrative

Added additional conclusion codes.

• Brand Name: GORE® DUALMESH® BIOMATERIAL
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MPD APC B/P; p.o. box 1408; elkton MD 21922 1408
• Manufacturer Contact: 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 10834179
• MDR Text Key: 216118679
• Report Number: 3003910212-2020-01135
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K992189
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 73 YR
• Patient Sex: Male