MAUDE Adverse Event Report: ACELL, INC. PELVIC FLOOR MATRIX

Model Number	PFM0912
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Prolapse (2475)
Date of Event	04/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr is being submitted due to the study subject participant reported adverse event (ae) of recurrent prolapse.There was no reports of device failure at the time of index and follow up surgery.The acell device was not explanted.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.
Event or Problem Description
On 6/19/2019 acell, inc.Received an adverse event through the (b)(6) registry from our (b)(6) postmarket surveillance studies on transvaginal pelvic mesh placement for the treatment of pelvic organ prolapse (pop).During the evaluation of the adverse event, we learned that the product solyx (boston scientific) was also involved in the incident.The study subject is experiencing continuing recurrent prolapse following pelvic floor repair with an acell's device and boston scientific solyx product.The index pop repair procedure was conducted on (b)(6) 2018 and the adverse event onset was (b)(6) 2019.Additional surgical treatment was performed on (b)(6) 2019.There was no procedural complication at the time of index and follow up surgery.The acell device was not explanted.

• Brand Name: PELVIC FLOOR MATRIX
• Common Device Name: PELVIC FLOOR MATRIX
• Manufacturer (Section D): ACELL, INC.; 6640 eli whitney dr.; columbia MD 21046
• MDR Report Key: 8803568
• Report Number: 3005920706-2019-00015
• Device Sequence Number: 13534741
• Product Code: FTM
• UDI-Device Identifier: 00386190001288
• UDI-Public: (01)00386190001288(17)191031(10)010652
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K141084
• 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): 06/19/2019

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: 10/31/2019
• Device Model Number: PFM0912
• Device Catalogue Number: PFM0912
• Device Lot Number: PD000965
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 07/18/2019
• 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: Other
• Patient Age: 72 YR
• Patient Weight: 76