MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM; MESH, SURGICAL

Catalog Number 2025002

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

Patient Problem Hernia (2240)

Event Date 11/06/2015

Event Type  Injury  

Event Description

It was reported through a legal event that a (b)(6) man underwent a hernia repair surgery on or about (b)(6) 2014.During the hernia repair surgery, the surgeon implanted a strattice mesh in him.After surgery, the patient returned to the hospital on or about (b)(6) 2015 for a revision surgery.Subsequently, the patient returned to the hospital again on or about (b)(6) 2016 for a mesh explant surgery.

Manufacturer Narrative

This legal event is being reported as serious injury due to the reported recurrence with device explant.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.

Manufacturer Narrative

Internal investigation into strattice lot sp100102 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 10/12/2022, of the 191 devices released to finished goods for lot sp100102, 184 have been distributed with 127 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.As reported in the initial: this legal event is being reported as serious injury due to the reported recurrence with device explant.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

This is follow up#1 to report on september 19, 2022, pmqa received notification from legal that the lots associated with this event were found through discovery and are sp100102-167 and sp100253-246.No other information was provided.This record is associated with sp100102-167.As reported in the initial: it was reported through a legal event that a 69 year old man underwent a hernia repair surgery on or about (b)(6) 2014.During the hernia repair surgery, the surgeon implanted a strattice mesh in him.After surgery, the patient returned to the hospital on or about november 6, 2015 for a revision surgery.Subsequently, the patient returned to the hospital again on or about (b)(6) 2016 for a mesh explant surgery.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 20 X 25, FIRM
• Type of Device: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 13663323
• MDR Text Key: 286873115
• Report Number: 1000306051-2022-00027
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2025002
• Device Lot Number: SP100102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/10/2022
• Initial Date FDA Received: 03/03/2022
• Supplement Dates Manufacturer Received: 09/19/2022
• Supplement Dates FDA Received: 10/13/2022
• 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: 69 YR
• Patient Sex: Male