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

Model Number PFM0912

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

Patient Problem Prolapse (2475)

Event Date 04/03/2019

Event Type  Injury  

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 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
• Type of Device: PELVIC FLOOR MATRIX
• Manufacturer (Section D): ACELL, INC.; 6640 eli whitney dr.; columbia MD 21046
• Manufacturer (Section G): ACELL, INC.; 6640 eli whitney dr.; columbia MD 21046
• Manufacturer Contact: barry brainard ; 6640 eli whitney dr.; columbia, MD 21046 ; 4109538558
• MDR Report Key: 8803568
• MDR Text Key: 151498753
• Report Number: 3005920706-2019-00015
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00386190001288
• UDI-Public: (01)00386190001288(17)191031(10)010652
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2019
• Initial Date FDA Received: 07/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 76