MAUDE Adverse Event Report: ST. JUDE MEDICAL CATD SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT; HEART-VALVE, MECHANICAL

Model Number	21VAVGJ-515
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Death (1802)
Date of Event	07/15/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
Information received from medical device registration form notes that on (b)(6) 2019, a 21mm masters valve was implanted.On the same day, the patient expired.
Additional Manufacturer Narrative
An event of patient death after the device was emergently implanted 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.
Event or Problem Description
(b)(6) 2019 jl: additional information received on this date reported that the patient had a ruptured aorta and cpr was in progress when brought into the or for the valve implant procedure.(b)(6) 2019 jl: additional information reported that the patient was brought to the or in grave condition; the patient had already ruptured and cpr was in progress when the patient was brought to the or from the icu.The graft was implanted, but the patient could not be weaned from bypass.Information received from medical device registration form notes that on (b)(6) 2019, a 21mm masters valve was implanted.On the same day, the patient expired.
Event or Problem Description
(b)(6) 2019 jl: additional information received on this date reported that the patient had a ruptured aorta and cpr was in progress when brought into the or for the valve implant procedure.(b)(6) 2019 jl: additional information reported that the patient was brought to the or in grave condition; the patient had already ruptured and cpr was in progress when the patient was brought to the or from the icu.The graft was implanted, but the patient could not be weaned from bypass.Information received from medical device registration form notes that on (b)(6) 2019, a 21mm masters valve was implanted.On the same day, the patient expired.

• Brand Name: SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 9084078
• Report Number: 2648612-2019-00065
• Device Sequence Number: 2802643
• Product Code: LWQ
• UDI-Device Identifier: 05414734009478
• UDI-Public: 05414734009478
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2020

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: 04/30/2022
• Device Model Number: 21VAVGJ-515
• Device Catalogue Number: 21VAVGJ-515
• Device Lot Number: 6307945
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 09/23/2019; 01/07/2020
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 10/22/2019; 01/07/2020
• 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
• Patient Age: 56 YR