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

Model Number MSPL0710

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

Patient Problem Dysphagia/ Odynophagia (1815)

Event Type  Injury  

Manufacturer Narrative

This mdr is being submitted due to the reported dysphagia which resulted in explantation of the acell device.The surgeon cannot confirm that the acell device was the cause of the reported symptom.The acell device was explanted, however, it is not available for evaluation.The surgeon is satisfied with the outcome of the patient.A review of the manufacturing records is not possible as the 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.There were no reports of device failure at the time of initial surgery.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 that a patient experienced dysphagia after implantation of a acell device for a hiatal hernia repair six (6) weeks post-operative.The date of implantation is unknown.The surgeon stated he explanted the acell device due to the patient experiencing dysphagia.The date of explantation is unknown.The surgeon cannot confirm that the acell device was related to the symptoms the patient reported, nevertheless, is satisfied with the outcome of the patient.

Manufacturer Narrative

This is a follow-up report for additional information that was received subsequent to the initial filing.The surgeon was unable to provide further information regarding this issue.Acell's investigation is complete.Initial - this mdr is being submitted due to the reported dysphagia which resulted in explantation of the acell device.The surgeon cannot confirm that the acell device was the cause of the reported symptom.The acell device was explanted, however, it is not available for evaluation.The surgeon is satisfied with the outcome of the patient.A review of the manufacturing records is not possible as the 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.

Event Description

On (b)(6) 2019, acell, inc.Was notified that a patient experienced dysphagia after implantation of a acell device for a hiatal hernia repair six (6) weeks post-operative.The date of implantation is unknown.The surgeon stated he explanted the acell device due to the patient experiencing dysphagia.The date of explantation is unknown.The surgeon cannot confirm that the acell device was related to the symptoms the patient reported, nevertheless, is satisfied with the outcome of the patient.

• 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
• MDR Report Key: 8552541
• MDR Text Key: 143239112
• Report Number: 3005920706-2019-00006
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K182259
• 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: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MSPL0710
• Device Catalogue Number: MSPL0710
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other