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

Model Number	23VAVGJ-515
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 9553938
• Report Number: 2648612-2020-00002
• Device Sequence Number: 19322800
• Product Code: LWQ
• UDI-Device Identifier: 05414734009522
• UDI-Public: 05414734009522
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention