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

Model Number	21AGN-751
Medical Device Problem Codes	Gradient Increase (1270); Obstruction of Flow (2423)
Health Effect - Clinical Code	Aortic Insufficiency (1715)
Date of Event	04/09/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2011, a 21mm regent heart valve was implanted.The patient presented with a high pressure gradient and one of the leaflets had restrictive motion and was not opening.Per report the patient had been on anticoagulation and was compliant.On (b)(6) 2018, the valve was explanted and another 21mm regent heart valve was implanted as the replacement.The patient has been discharged.
Additional Manufacturer Narrative
The reported event of high pressure gradient and restrictive motion in one leaflet could not be confirmed.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 sewing cuff had been removed prior to its return and no tissue was noted in the recessed pivot areas.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.
Event or Problem Description
On (b)(6) 2011, a 21mm regent heart valve was implanted.The patient presented in 2018 with a high pressure gradient and one of the leaflets had restrictive motion and was not opening.Per report the patient had been on anticoagulation and was compliant.On (b)(6) 2018, the valve was explanted and another 21mm regent heart valve was implanted as the replacement.The patient has been discharged.

• Brand Name: SJM REGENT HEART VALVE
• 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: 7611853
• Report Number: 2648612-2018-00041
• Device Sequence Number: 16522213
• Product Code: LWQ
• UDI-Device Identifier: 05414734005982
• UDI-Public: 05414734005982
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2018

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: 02/28/2021
• Device Model Number: 21AGN-751
• Device Catalogue Number: 21AGN-751
• Device Lot Number: 5407358
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 08/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR