MAUDE Adverse Event Report: ACELL, INC. GENTRIX SURGICAL MATRIX PLUS

Model Number MSPL1015

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

Patient Problems Wound Dehiscence (1154); Obstruction/Occlusion (2422)

Event Date 01/25/2019

Event Type  Injury  

Manufacturer Narrative

This mdr is being submitted due to the reported fascial dehiscence with bowel obstruction requiring emergent surgery and hospitalization. Upon exploration for management of the event, it was the operating surgeon's opinion that the fascial dehiscence was not the result of acell device failure; that the device performed as expected, that the fascial dehiscence was, in fact, the primary event and that the event resulted from patient factors and inherent patient comorbidities. The acell device was explanted and discarded by the hospital, it is not available for evaluation. A review of the manufacturing records for this lot identified no deviations in the production process. The device was manufactured and distributed sterile in compliance with fda, state, local laws and regulations, and acell's operating procedures. Acell conducted suture retention testing on the same retained lot which met specification.

Event Description

On (b)(6) 2019, acell, inc. Was notified by a surgeon that a patient had a fascial dehiscence with bowel obstruction requiring emergent surgery and hospitalization on (b)(6) 2019. The surgeon observed that the primary sutures used to close the defect had ruptured along with the implanted acell device which had been placed as an underlay. The surgeon informed acell that the patient had been non-complaint with post-operative activity instructions. The surgeon explanted and discarded the acell device. The subsequent repair was completed with a non-acell device, a synthetic mesh. There was no infection present after acell implantation or at acell explantation. The patient developed an infection after implantation of the synthetic mesh.

• Brand Name: GENTRIX SURGICAL MATRIX PLUS
• Type of Device: GENTRIX SURGICAL MATRIX PLUS
• Manufacturer (Section D): ACELL, INC.; 6640 eli whitney dr.; columbia MD 21046
• Manufacturer (Section G): ACELL, INC.; 6640 eli whitney dr.; columbia MD 21046
• Manufacturer Contact: barry brainard ; 6640 eli whitney dr.; columbia, MD 21046 ; 4109538558
• MDR Report Key: 8405977
• MDR Text Key: 138349783
• Report Number: 3005920706-2019-00003
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 10/31/2020
• Device Model Number: MSPL1015
• Device Catalogue Number: MSPL1015
• Device Lot Number: 014449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/08/2019 Patient Sequence Number: 1