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

Model Number	MSPL1015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Obstruction/Occlusion (2422)
Date of Event	01/25/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: GENTRIX SURGICAL MATRIX PLUS
• Manufacturer (Section D): ACELL, INC.; 6640 eli whitney dr.; columbia MD 21046
• MDR Report Key: 8405977
• Report Number: 3005920706-2019-00003
• Device Sequence Number: 1811097
• Product Code: FTM
• UDI-Device Identifier: 00386190001240
• UDI-Public: (01)00386190001240(17)201031(10)014449
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K162559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/12/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: MSPL1015
• Device Catalogue Number: MSPL1015
• Device Lot Number: 014449
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 163