MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 25 X 40, FIRM; MESH, SURGICAL

Catalog Number 2540002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735); Necrosis (1971)

Event Date 01/15/2015

Event Type  Injury  

Manufacturer Narrative

This legal event is being reported as serious injury due to the reported complications with surgical intervention.The lot associated with this event was not reported and remains unknown; therefore a review of the device history records could not be performed.No strattice devices were returned for evaluation.Based on the limited information reported, a relationship between the event and strattice cannot be confirmed.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.

Event Description

It was reported through a legal event that a (b)(6) year old female patient had ventral incisional hernia repair surgery on or about (b)(6) 2014.During the hernia repair surgery, the surgeon implanted a strattice mesh.After surgery, the patient returned to the hospital on or about (b)(6) 2015 and was diagnosed with ischemic necrosis of the central portion of her midline incision.On or about (b)(6) 2015, the patient underwent the excision and debridement of an open abdominal wound.On or about (b)(6) 2015, the patient underwent abdominal wall debridement with wound vac placement.The strattice mesh was noted to have separated from the healing tissue and was incised.The patient presented several more times throughout 2015 for treatment of abdominal wall pain, wound infection, and dehiscence, and underwent additional excisional debridement of abdominal wound.

Manufacturer Narrative

Internal investigation into strattice lot sp100130 included a review of the reported information, review of the device history records, and a review of the complaint history records.The investigation resulted in no remarkable findings, including no other complaints reported against the lot and no deviations or related non-conformances revealed during processing.The lot was terminally sterilized within the process parameters and met all qc release criteria.As of 9/23/2022, of the (b)(4) devices released to finished goods for lot sp100130, (b)(4) have been distributed with (b)(4) reported as implanted.Based on our internal investigation with no remarkable findings, and without relevant patient factors, a relationship between the strattice and this event could not be determined.Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.

Event Description

This is follow up#1 to report on 9/14/2022, pmqa received notification from legal that the lot associated with this event was found through discovery and is sp100130-005.No other information was reported.As reported in the initial: it was reported through a legal event that a 48 year old female patient had ventral incisional hernia repair surgery on or about (b)(6) 2014.During the hernia repair surgery, the surgeon implanted a strattice mesh.After surgery, the patient returned to the hospital on or about (b)(6) 2015 and was diagnosed with ischemic necrosis of the central portion of her midline incision.On or about (b)(6) 2015, the patient underwent the excision and debridement of an open abdominal wound.On or about (b)(6) 2015, the patient underwent abdominal wall debridement with wound vac placement.The strattice mesh was noted to have separated from the healing tissue and was incised.The patient presented several more times throughout 2015 for treatment of abdominal wall pain, wound infection, and dehiscence, and underwent additional excisional debridement of abdominal wound.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 25 X 40, FIRM
• Type of Device: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 13845499
• MDR Text Key: 287596039
• Report Number: 1000306051-2022-00042
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2540002
• Device Lot Number: SP100130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NO INFORMATION REPORTED.
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female