MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE; HEART-VALVE, MECHANICAL

Model Number 17MHPJ-505

Device Problem Biocompatibility (2886)

Patient Problem Complete Heart Block (2627)

Event Date 06/11/2020

Event Type  Injury  

Manufacturer Narrative

An event of heart block was reported.A more comprehensive assessment could not be performed as the device remains implanted was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related reference manufacturing report number: 3007113487-2020-00018.On (b)(6) 2017, a 15mm masters mitral valve was implanted.On (b)(6) 2020, the patient was admitted for planned mitral valve repair due to worsening mitral valve stenosis and pulmonary hypertension.On (b)(6) 2020, the mitral valve was explanted and a new 17mm masters mitral valve was successfully implanted.On (b)(6) 2020, the patient developed first degree heart block, complete heart block, and junctional rhythm.Therefore, on (b)(6) 2020, an epicardial pacemaker was implanted.The patient is reported to be recovering.Clinical study patient id: (b)(6).

• Brand Name: SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE
• 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
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725 ; RQ 00725
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10339057
• MDR Text Key: 200821395
• Report Number: 2648612-2020-00080
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734030496
• UDI-Public: 05414734030496
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 17MHPJ-505
• Device Catalogue Number: 17MHPJ-505
• Device Lot Number: 7113403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 15MHPJ-505
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR
• Patient Weight: 14