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

Model Number	19AGN-751
Medical Device Problem Codes	Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	03/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017, an aortic valve replacement (avr) was performed and a 19mm regent valve was implanted in a female patient.During a follow-up visit on (b)(6) 2019, the patient presented with chest pain and was treated with a thrombolysis course; however, symptoms progressed.The patient underwent a re-do avr procedure and a trifecta gt valve (serial number: unknown) was implanted.The patient is reported to be discharged.
Event or Problem Description
On (b)(6) 2017, an aortic valve replacement (avr) was performed and a 19mm regent valve was implanted in a female patient.During a follow-up visit on (b)(6) 2019, the patient presented with chest pain and was treated with a thrombolysis course; however, symptoms progressed.The patient underwent a re-do avr procedure and a trifecta gt valve (serial number: (b)(4)) was implanted and the patient has been discharged.Per the physician, pannus was observed on the explanted valve.
Event or Problem Description
On (b)(6) 2017, an aortic valve replacement (avr) was performed and a 19mm regent valve was implanted in a female patient.During a follow-up visit on (b)(6) 2019, the patient presented with chest pain and was treated with a thrombolysis course; however, symptoms progressed.The patient underwent a re-do avr procedure and a trifecta gt valve (serial number: (b)(4)) was implanted and the patient has been discharged.Per the physician, pannus was observed on the explanted valve.
Additional Manufacturer Narrative
Explant was reported due to chest pain and pannus was noted on the explanted valve.Pannus was present on the sewing cuff and extended onto parts of the orifice, but did not impinge upon the leaflets.Both leaflets opened and closed completely and without resistance.No inflammation was present.Surface fungal hyphae were present on the tissue and was interpreted by histopathology to be a contaminant.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.This included sterilization of the device to prevent contamination.The cause of the pannus and fungal hyphae 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: 8497612
• Report Number: 2648612-2019-00024
• Device Sequence Number: 1663799
• Product Code: LWQ
• UDI-Device Identifier: 05414734005869
• UDI-Public: 05414734005869
• 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: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2019

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: 05/19/2020
• Device Model Number: 19AGN-751
• Device Catalogue Number: 19AGN-751
• Device Lot Number: 5098104
• 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: 03/30/2019
• Supplement Date Received by Manufacturer: 04/09/2019; 06/21/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 04/22/2019; 07/18/2019
• 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: Hospitalization; Required Intervention