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

Model Number 25AGFN-756

Device Problems Backflow (1064); Incomplete Coaptation (2507)

Patient Problems Aortic Regurgitation (1716); Thrombus (2101)

Event Date 07/29/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.Investigation results will be provided in a subsequent submission.

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 201529473
• Report Number: 3003681312-2020-00010
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006262
• UDI-Public: 05414734006262
• 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,foreig
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 70