MAUDE Adverse Event Report: ST. JUDE MEDICAL CATD SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT; HEART-VALVE, MECHANICAL

Model Number 23VAVGJ-515

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

As the physician was putting sutures through the sewing cuff of a 23vavgj product, sewing cuff began to pull away from valve.¿ it was like the sewing cuff was disintegrating¿.The valve was replaced with a 23 mm onx valved graft.

Event Description

As the physician was putting sutures through the sewing cuff of a 23vavgj product, sewing cuff began to pull away from valve.¿ it was like the sewing cuff was disintegrating¿.The valve was replaced with a 23 mm onx valved graft.

Manufacturer Narrative

Additional information sections: b5, d10, h3, h6, h10.The reported event of the sewing cuff beginning to pull away from the valve was confirmed.The investigation found one of the loops of the suture holding the cuff in place was broken, which could cause loosening of the cuff.The knots of the suture were intact and no evidence was found to suggest that the damage occurred during manufacturing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported event could not be conclusively determined.

• Brand Name: SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 9553938
• MDR Text Key: 173895284
• Report Number: 2648612-2020-00002
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734009522
• UDI-Public: 05414734009522
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/16/2020

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: 05/31/2023
• Device Model Number: 23VAVGJ-515
• Device Catalogue Number: 23VAVGJ-515
• Device Lot Number: 6890040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 01/06/2020
• Supplement Dates Manufacturer Received: 02/25/2020
• Supplement Dates FDA Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention