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

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

Patient Problem Failure to Anastomose (1028)

Event Type  Injury  

Manufacturer Narrative

This mdr is being submitted due to the reported anastomotic leak after initial placement of the acell device.The acell device was explanted; however it is not available for evaluation.A review of the manufacturing records is not possible as the acell device, lot and serial number was not provided by the surgeon.Nevertheless, all acell devices are manufactured and distributed sterile in compliance with fda, state, local laws and regulations, and acell's operating procedures.We are submitting this report now, however, the investigation is ongoing and more information will be provided upon completion of the investigation.

Event Description

On (b)(6) 2019, acell, inc.Was notified by a physician that their patient developed an anastomotic leak and became septic, four (4) days after performing an anastamosis repair wrapped with an acell gentrix device.The surgeon was unable to provide the date of the surgery and the acell device used.We are submitting this report now, however, the investigation is ongoing and more information will be provided upon completion of the investigation.

Event Description

This is a follow-up report for additional and corrected information that was received subsequent to the initial filing.On (b)(6) 2019, acell, inc.Was notified by a physician that their patient developed an anastomotic leak and became septic, four (4) to five (5) days after perfoming an anastamosis repair wrapped with an acell gentrix device in 2014.The physician was unable to provide the date of the surgery and device lot and serial number.The physician stated he does not attribute the implanted acell device to the anastomotic leak.The physician repaired the leak, however, the patient developed a bowel obstruction six (6) to seven (7) months later.

Manufacturer Narrative

This is a follow-up report for additional information that was received subsequent to the initial filing.The physician was unable to provide further information regarding the issue in subsequent follow-up conversations.The initial mdr was submitted due to the reported anastomotic leak after initial placement of the acell device.The acell device was explanted; however it is not available for evaluation.A review of the manufacturing records is not possible as the acell device, lot and serial number was not provided by the surgeon.Nevertheless, all acell devices are manufactured and distributed sterile in compliance with fda, state, local laws and regulations, and acell's operating procedures.Acell's investigation is complete.

• Brand Name: GENTRIX SURGICAL MATRIX THIN
• Type of Device: GENTRIX SURGICAL MATRIX THIN
• Manufacturer (Section D): ACELL, INC.; 6640 eli whitney dr.; columbia MD 21046
• MDR Report Key: 8745294
• MDR Text Key: 149546176
• Report Number: 3005920706-2019-00013
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K162554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/01/2019

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2019
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: 06/01/2019
• Supplement Dates FDA Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention