MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM MASTERS SERIES HEART VALVE W/TEFLON CUFF; HEART-VALVE, MECHANICAL

Model Number	25ATJ-503
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, a bentall procedure was performed and a 25mm sjm masters series heart valve w/teflon cuff was implanted and a j graft shield neo valsalva (jnvt-2809, serial# (b)(4)) was concomitantly implanted.After closing the patient's chest, the leaflets stuck in the closed state.The physician re-opened the patient's chest and the valve was rotated approximately 30 degrees.By shaking the heart, the leaflet started operating again.The procedure was completed without replacing the valve.It was noted the patient went into ventricular fibrillation (vf) after the procedure, but the user does not associate that with the valve.
Additional Manufacturer Narrative
An event of the valve leaflets sticking in the closed position after implant was reported.The results of the investigation are inconclusive since the device remains implanted and was not accessible for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SJM MASTERS SERIES HEART VALVE W/TEFLON CUFF
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 9265607
• Report Number: 2648612-2019-00090
• Device Sequence Number: 11417173
• Product Code: LWQ
• UDI-Device Identifier: 05414734022217
• UDI-Public: 05414734022217
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2019

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: 07/20/2022
• Device Model Number: 25ATJ-503
• Device Catalogue Number: 25ATJ-503
• Device Lot Number: 6071858
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 12/20/2019
• 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
• Patient Age: 28 YR
• Patient Weight: 57