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	Adhesion(s) (1695); Seroma (2069); Obstruction/Occlusion (2422)
Date of Event	11/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is being submitted due to the reported occurrence of adhesions and bowel obstruction three months after the initial placement of the acell device.Upon further discussions with the explanting surgeon on 4/10/2018, it was determined that the patient developed a seroma shortly post operatively requiring drainage, and it was felt that the presence of the obstruction may have been caused not only by the recurrent adenocarcinoma, but also due to the implantation of the device during the hernia repair.The acell device may have led to the formation of adhesions to the surgical closure; which caused the development of the bowel obstruction, that necessitated operative intervention and partial device explantation.The explanted device was evaluated by hospital pathologist which revealed the presence of adherent omentum containing recurrent adenocarcinoma.A review of the manufacturing records for this lot identified no deviations in the production process that fall outside of specification.The device was manufactured and distributed sterile in compliance with fda, state, local, and acell's operating procedures.There were no reports of device failure at the time of initial surgery.
Event or Problem Description
Patient had a ventral hernia repair surgery conducted on (b)(6) 2017.An exploratory laporatomy on (b)(6) 2017 revealed the patient had multiple adhesions and multiple loops of small bowel stuck together with an acell surgical sheet.The adhesions were removed, the bowel resected and the acell surgical sheet was partially explanted.Hospital pathology results indicated the presence of adenocarcinoma in mesenteric tissue a follow up ct discovered diffuse adenocarcinoma throughout the bowel.The surgeon at the time believed that the complications were due to the spread of cancer post-operatively, not due to the acell surgical sheet.On 4/10/2018 acell received notification during a follow-up call between chief science officer and surgeon, it was discovered that patient developed a seroma post operative which was drained percutaneously.Additionally, it was the surgeon's opinion the diffuse cancer was the primary reason for adhesion formation.The development of adhesions to the surgical closure, which included an acell surgical sheet, may have led to the development of the bowel obstruction discovered on (b)(6) 2017, which necessitated operative intervention.It was this clarification on (b)(6) 2018 that prompted the reconsideration of this event from customer feedback based upon the primary reason for the complication being cancer, to reportable based upon the potential involvement of the device in the development of the bowel obstruction.

• 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: 7494927
• Report Number: 3005920706-2018-00001
• Device Sequence Number: 19258653
• Product Code: FTM
• UDI-Device Identifier: 00386190001240
• UDI-Public: (01)00386190001240(17)190630(10)009504
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K162554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2018

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: Physician
• Device Expiration Date: 06/30/2019
• Device Model Number: MSPL1015
• Device Catalogue Number: MSPL1015
• Device Lot Number: 009504
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 05/08/2018
• 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: Other; Required Intervention
• Patient Age: 63 YR