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

Model Number	25AGFN-756
Medical Device Problem Codes	Backflow (1064); Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Aortic Regurgitation (1716); Thrombus (2101)
Date of Event	07/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information regarding this event has been requested.Investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2020.A patient had an echocardiogram performed for an unrelated reason and it revealed the patient had significant regurgitation and a gradient of 25mmhg.The patient was given vitamin k for the concern of clot formation.Upon explant there appeared to be a clot that they could see and no tissue impinging on the valve.Upon review, it looked as though they leaflets were opening/closing in an asymmetrical manner and hence the decision to remove and put in a masters hp valve.
Event or Problem Description
On (b)(6) 2020.A patient had an echocardiogram performed for an unrelated reason and it revealed the patient had significant regurgitation and a gradient of 25mmhg.The patient was given vitamin k for the concern of clot formation.Upon explant there was no tissue impinging on the valve or any clots observed.Upon review, it looked as though they leaflets were opening/closing in an asymmetrical manner and hence the decision to remove and put in a masters hp valve.
Additional Manufacturer Narrative
The asymmetric leaflet movement could not be confirmed.Morphological and hydrodynamic examination indicated the valve met abbott specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Hydrodynamic testing at the time of manufacturing and upon return to abbott indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.The cause of the reported event remains unknown.

• Brand Name: SJM REGENT HEART VALVE W/FLEX 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 ; RQ 00725
• MDR Report Key: 10358557
• Report Number: 3003681312-2020-00010
• Device Sequence Number: 3462555
• Product Code: LWQ
• UDI-Device Identifier: 05414734006262
• UDI-Public: 05414734006262
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/21/2024
• Device Model Number: 25AGFN-756
• Device Catalogue Number: 25AGFN-756
• Device Lot Number: 7239855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/29/2020
• Supplement Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 10/08/2020
• 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: Life Threatening; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 70