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

Model Number 19AGFN-756

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Death (1802)

Event Date 06/26/2019

Event Type  malfunction  

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 Description

On (b)(6) 2019, a 21 mm regent heart valve was implanted.Post implant, the leaflets were observed to be immobile.The site attempted to re-position the valve, during which one of the valve leaflets detached.The valve was removed and replaced with a 19 mm mechanical heart valve (model: unknown).The site attempted to re-position the leaflets, but were unable to rotate the device.A post-surgery eco showed that the valve was working normally.The patient expired 48 hours post procedure.Additional information has been requested.

Manufacturer Narrative

09/25/2019 mjr ¿ supplemental correction report needed for corrected implanted device serial and model number, d4.09/25/2019 mjr - supplemental report needed to address analysis: h3, h6.An event of inability to rotate the device and patient death two days after procedure was reported.Information from the field indicated that the valve was working normally after the surgery.The results of the investigation are inconclusive since 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 at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SJM REGENT HEART 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
• MDR Report Key: 8828688
• MDR Text Key: 152493433
• Report Number: 2648612-2019-00052
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734005982
• UDI-Public: 05414734005982
• Combination Product (y/n): N
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2023
• Device Model Number: 19AGFN-756
• Device Catalogue Number: 19AGFN-756
• Device Lot Number: 6586351
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention