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

Model Number	PSMX0710
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Date of Event	11/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is being submitted due to the reported dysphagia which resulted in a two night hospitalization.The patient did not require intervention for the dysphagia and is now asymptomatic.The surgeon cannot confirm that the acell device was the cause of the reported symptoms.The surgeon is satisfied with the outcome of the patient.The acell device was not explanted and 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.There were no reports of device failure at the time of initial surgery.
Event or Problem Description
On 1/15/19, acell, inc.Was notified by a physician that their patient was complaining of having difficulty swallowing 9 weeks post-operative.The surgeon conducted a gastric bypass and hiatal hernia repair with an acell device on (b)(6) 2018.The patient presented with the symptoms at the er 9 weeks post-operative; an index ct scan was conducted which showed some narrowing.The patient was admitted to the hospital for 2 days.A ugi series and an egd with eus were performed.The results indicated the distal esophagus was patent with no obstruction and the eus revealed no significant fluid present.The patient did not require intervention for the dysphagia and is now asymptomatic.The surgeon cannot confirm that the acell device was related to the symptoms the patient reported and is satisfied with the outcome of the patient.The device was not explanted.

• Brand Name: GENTRIX SURGICAL MATRIX
• Common Device Name: GENTRIX SURGICAL MATRIX PLUS
• Manufacturer (Section D): ACELL, INC.; 6640 eli whitney dr.; columbia MD 21046
• MDR Report Key: 8335351
• Report Number: 3005920706-2019-00002
• Device Sequence Number: 19237424
• Product Code: FTM
• UDI-Device Identifier: 00386190001370
• UDI-Public: (01)00386190001370(17)190531(10)008990
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/15/2019

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: 05/31/2019
• Device Model Number: PSMX0710
• Device Catalogue Number: PSMX0710
• Device Lot Number: 008990
• 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: 02/13/2019
• 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