MAUDE Adverse Event Report: CORCYM CANADA CORP CARBOMEDICS CARDIOFIX PERICARDIUM; TISSUE PATCH

Model Number CF68

Device Problems Detachment of Device or Device Component (2907); Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Date 11/02/2011

Event Type  Injury  

Event Description

A cardiofix pericardial patch cf68 was placed in 2009.The patch was removed on (b)(6) 2011.The site identified there was concern for allergic reaction based on the pathology.

Manufacturer Narrative

Information received through the pathology report confirmed that the explanted asd patch presented acellular eosinophilic material lined by mixed cellular inflammation, predominantly histiocytes, eosinophils, and multinucleate giant cells.The sampled mitral annulus contained fibrotic tissue with acute and chronic inflammation and hemosiderosis.The excised sample of atrial septal defect patch analysis showed an extensively fibrotic tissue containing embedded suture material and exhibiting calcification and ossification with recruitment of hematopoietic marrow elements.Since the product was not returned to the manufacturer, no further investigation is possible at this time and a definitive root cause cannot be established for this event.The manufacturer is conducting a review of the device history records for the device involved in the reported event and will provide an update upon completion.

Event Description

A cardiofix pericardial patch cf 68 was placed on (b)(6) 2009 as part of a repair of residual atrial septal defect.No procedural complications were reported, and the patient tolerated the procedure well.The manufacturer was informed that the patch was removed on (b)(6) 2011 and there was concern for allergic reaction based on the pathology.Prior to the re-intervention in (b)(6) 2011, the patient had developed signs of recurrent atrial septal defect with a large interatrial communication.The echocardiogram showed a very floppy interatrial patch.Significant bidirectional shunting was noted, and the patient was refereed for an atrial septal defect closure.At the time of the re-intervention, during inspection of the interatrial septum, it was noted that the previous atrial septal patch appeared to be disintegrating.It had completely detached in the center and was quite friable.This was excised as a single patch.The large atrial communication was then closed with a patch of gore-tex 1 mm thick material.The procedure was completed with no complications and the patient tolerated the procedure well.

Manufacturer Narrative

The manufacturing and material records for the cardiofix pericardial patch, model # cf 68 , s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve satisfied all material, visual, and performance standards required for a model cf 68 cardiofix pericardial patch at the time of manufacture and release.Since the product was not returned to the manufacturer, no further investigation is possible at this time.Based on the available information, it is not possible to establish a definitive root cause for the reported event.However, per the document review performed, no manufacturing deficiencies were identified.Should further information become available in the future, a follow up report will be provided to this activity.

Event Description

See intial report.

• Brand Name: CARBOMEDICS CARDIOFIX PERICARDIUM
• Type of Device: TISSUE PATCH
• Manufacturer (Section D): CORCYM CANADA CORP; 5005 north fraser way; burnaby V5J 5 M1; CA V5J 5M1
• MDR Report Key: 10764270
• MDR Text Key: 213944940
• Report Number: 1718850-2020-01181
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 07/30/2021,08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2010
• Device Model Number: CF68
• Device Catalogue Number: CF68
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/30/2021
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2021
• Date Manufacturer Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR