MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. C-QUR V-PATCH

Model Number 31202

Device Problem Insufficient Information (3190)

Patient Problem Urinary Tract Infection (2120)

Event Date 05/23/2014

Event Type  Injury  

Event Description

Received a medwatch stating that a pt has a mesh implanted for ventral hernia and experienced complications.

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation into this event.

Manufacturer Narrative

Multiple attempts to collect additional information from the complainant were not successful.Engineering: lot history, release criteria and sterilization records were reviewed.The lot met all incoming inspection for suture and ball burst of the bare mesh as well as the identity of the omega three fatty acids.The quality control in-process testing completed for each sub-assembly met all release criteria including visual inspection, pouch peel and stitch strength analysis.The lot met all release criteria prior to sending to the sterilizer.It was confirmed that the lot met all sterilization cycle criteria.Clinical evaluation: inadequate suture fixation may lead to mesh contracture and other complications requiring surgical intervention.Complications may occur due to an inadequate suture fixation and/or inadequate overlap which will cause separation of the mesh from the abdominal wall thereby increasing the possibility of infection, perforation, seroma, adhesions, fistula formation and pain.

Manufacturer Narrative

Medical record reveals contributing past medical history of ventral hernia repair x 2 and hysterectomy prior to c-qur implant.The procedure in (b)(6) 2014 revealed 2 hernias requiring repair with a single mesh.One was midline and connected to a smaller umbilical hernia.Repair was subfascial and secured with 8 prolene sutures.The exploratory and explant was performed in (b)(6) 2014.Findings included superficial placement of mesh product with sutures intact, adhesions, no drainage and no evidence of infection.The mesh was removed easily without excision.Cultures sent of the mesh were negative.Cultures sent from the abdominal wound had gram negative rods and gram positive cocci.

Event Description

Explant report found inflammation but did not look like infection.Lab results a few white blood cells seen but no organism growth.

• Brand Name: C-QUR V-PATCH
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH
• Manufacturer Contact: theresa morin ; 5 wentworth drive; hudson, NH 03051 ; 6038645237
• MDR Report Key: 4792727
• MDR Text Key: 5816855
• Report Number: 1219977-2015-00151
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K080688
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 04/30/2017
• Device Model Number: 31202
• Device Catalogue Number: 31202
• Device Lot Number: 203053
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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: 57 YR
• Patient Weight: 92