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

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

Patient Problems Pain (1994); Prolapse (2475)

Event Date 07/01/2014

Event Type  Injury  

Manufacturer Narrative

Lot/serial number for the device involved was not provided, and sales records were not able to identify a device for this event.This report includes details for the most likely product line given the surgery described.However, unlike synthetic devices which are designed to persist within the human body, acell devices are biological (porcine tissue) based devices designed to be reabsorbed within a finite period of time.It is extremely improbable that an acell device would persist at 12 months or at 3 years post implantation, which are the circumstances described in this event.This mdr has been filed out of an abundance of caution.

Event Description

In 2013, a (b)(6) old female patient underwent da vinci assisted laparoscopic sacrocolpopexy using a surgical mesh device at central baptist hospital.The mesh was placed anteriorly for cystocele correction and attached to her cervix.In 2014 it was identified that she had exposed mesh, mesh erosion into the vagina at the cervix and the distal end of the anterior arm, below the bladder.She had two excisions and conservative treatment with pessaries to support the anterior compartment but has pain and discomfort.She is currently taking vaginal estrogen as treatment.

• Brand Name: MATRISTEM 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 ; 8034870493
• MDR Report Key: 6830795
• MDR Text Key: 83986197
• Report Number: 3005920706-2017-00005
• Device Sequence Number: 1
• Product Code: FTM
• 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: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/31/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention; Disability
• Patient Age: 44 YR