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

Model Number PSMT1620

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

Patient Problems Abscess (1690); Fever (1858)

Event Date 03/20/2019

Event Type  Injury  

Manufacturer Narrative

This mdr is being submitted due to the reported abscess and explantation after initial placement of the acell device.The device was not returned to acell for further investigation.A review of the manufacturing records for this lot identified no deviations in the production process that fall outside of specification.The device was manufactured and distributed sterile in compliance with acell's operating procedures and federal, state, and local laws and regulations.

Event Description

On 3/25/2020, acell, inc."recieved" a medwatch "notificaftion" that a patient experienced an abscess following a ventral and incisional hernia repair reinforced with gentrix thick and a hysterectomy on (b)(6) 2019.The original surgery on (b)(6) 2019 was a double procedure a ventral and incision hernia repair and a hysterectomy including work that involved the perineum which potentially caused a contaminated operative field.The ventral and incision hernia repair was necessary due to a prior surgery conducted some time in 2006.The 2006 surgery was for an internal hernia that caused bowel obstruction, specifically it was a left paraduodenal hernia at the jd junction that caused the bowel obstruction.There was a tear in mesentery of the small bowel.During the surgery, adhesion were discovered ; however the patient had no prior surgery before this procedure in 2006.Additional, hernias developed as a result of this surgery in 2006.The (b)(6) 2019 surgery was conducted via a midline incision from the breast bone to the pubis.An anterior onlay patch of the gentrix thick device was placed on the muscle fascia and sutured with interrupted sutures.There were two drains placed during this surgery.Patient developed multiple pulmonary embolisms post op which were resolved during the hospital stay.Nevertheless, further complications developed after patient was discharged on (b)(6) 2019 that included abscess, fever and pain.The wound had achieved primary closure for some time and the complications she experienced developed after the wound closure.The acell device was partially explanted on (b)(6) 2019 and a wound vac was placed for 8 weeks.On (b)(6) 2019 the remaining acell device was explanted.The patient has further developed another hernia (umbilical) in the top anterior portion of the wound and is facing another surgery.

• Brand Name: GENTRIX SURGICAL MATRIX THICK
• Type of Device: GENTRIX SURGICAL MATRIX THICK
• Manufacturer (Section D): ACELL, INC.; 6640 eli whitney drive; columbia, md
• Manufacturer (Section G): ACELL, INC.; 6640 eli whitney dr.; columbia, md
• Manufacturer Contact: barry brainard ; 6640 eli whitney dr.; columbia, md ; 9538558
• MDR Report Key: 9982755
• MDR Text Key: 188994563
• Report Number: 3005920706-2020-00003
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00386190001790
• UDI-Public: (01)00386190001790(17)201130(10)014665
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: PSMT1620
• Device Catalogue Number: PSMT1620
• Device Lot Number: 014665
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2018
• 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
• Patient Age: 53 YR