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

Model Number	21AGN-751
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Aortic Regurgitation (1716)
Date of Event	04/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, a 21mm regent valve was implanted.On (b)(6) 2019, echo indicated leaflet obstruction accompanied by moderately high gradient (mean = 28mmhg, peak = 48mm hg) and moderate regurgitation.Acceleration time was 111ms, and aortic regurgitation pressure half time was 347ms.On (b)(6) 2019, the regent valve was explanted, and a replacement 21mm regent valve was implanted.The patient is reported to be in stable condition.Upon explant, no obvious thrombus or tissue growth on the valve was observed.Additional information has been requested.
Event or Problem Description
On (b)(6) 2019, a 21mm regent valve was implanted.On (b)(6) 2019, echo indicated leaflet obstruction accompanied by moderately high gradient (mean=28mmhg, peak=48mm hg) and moderate regurgitation.Acceleration time was 111ms, and aortic regurgitation pressure half time was 347ms.On (b)(6) 2019, the regent valve was explanted, and a replacement 21mm regent valve was implanted.The patient is reported to be in stable condition.Upon explant, no obvious thrombus or tissue growth on the valve was observed.
Additional Manufacturer Narrative
The reported event of leaflet obstruction, high gradient, and regurgitation was reported.One of the leaflets was confirmed to have limited mobility.Thrombus with microcalcifications were present in the pivot recesses.No inflammation was present.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.The cause of the leaflet obstruction and thrombus could not be conclusively determined.

• 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: 8562056
• Report Number: 2648612-2019-00033
• Device Sequence Number: 19295786
• Product Code: LWQ
• UDI-Device Identifier: 05414734005982
• UDI-Public: 05414734005982
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2019

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: 06/11/2023
• Device Model Number: 21AGN-751
• Device Catalogue Number: 21AGN-751
• Device Lot Number: 6497788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/06/2019
• Supplement Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 07/16/2019
• 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: 38 YR