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

Model Number	21AECJ-502
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Death (1802); Low Blood Pressure/ Hypotension (1914)
Date of Event	03/22/2019
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2019, a 21mm masters series valve was implanted in a (b)(6) female.On (b)(6) 2019, the patient collapsed in the icu.An echo performed revealed one of the leaflets was not moving and the other was partially coapting, resulting in a high gradient and hypotension.The patient's native annulus was reported to be severely calcified.A re-do procedure was performed and the patient was unable to sustain the operation and expired on (b)(6) 2019, due to persistent hypotension and renal failure.
Additional Manufacturer Narrative
An event of an obstructed leaflets, with resulting high gradient and hypotension was reported.The results of the investigation are inconclusive since the device 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 at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.Information from the field indicated that the patient's native annulus was severely calcified.The patient reportedly died following a re-do procedure due to persistent hypotension and renal failure.
Event or Problem Description
On (b)(6) 2019, a 21mm masters series valve was implanted in a (b)(6) female.On (b)(6) 2019, the patient collapsed in the icu.An echo performed revealed one of the leaflets was not moving and the other was partially coapting, resulting in a high gradient and hypotension.The patient's native annulus was reported to be severely calcified; however, no sub-annular tissue or thrombus was observed at the time of the procedure.A re-do procedure was performed and the patient was unable to sustain the operation and expired on (b)(6) 2019, due to persistent hypotension and renal failure.

• Brand Name: SJM MASTERS SERIES VALVE EXPANDED CUFF
• 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: 8562210
• Report Number: 2648612-2019-00025
• Device Sequence Number: 1587102
• Product Code: LWQ
• UDI-Device Identifier: 05414734053884
• UDI-Public: 05414734053884
• 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
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/19/2023
• Device Model Number: 21AECJ-502
• Device Catalogue Number: 21AECJ-502
• Device Lot Number: 6747797
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 05/13/2019
• 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: Death; Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 56