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

Model Number 27MECJ-502

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problem Death (1802)

Event Date 02/02/2020

Event Type  Death  

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) 2020, a 27mm masters series valve was implanted without any inconveniences and the patient was reported stable post implant.After moving the patient to recovery on (b)(6) 2020, the patient suffered hemodynamic decompensation.An echocardiogram was performed and the physician decided to re-operate.On (b)(6) 2020, during re-operation it was noted that one of the leaflets had dislodged and the other leaflet could not be found.Another 27mm masters series valve was implanted and the patient was moved to recovery.On (b)(6) 2020, the patient had expired and it is unknown if the valve led to the patient's death.Additional information was requested but cannot be obtained.

Manufacturer Narrative

An event of leaflet dislodgement following implant was reported.A more comprehensive assessment could not be performed since the device was not returned for analysis, and as attempts abbott medical affairs personnel to obtain more information surrounding the case was unsuccessful.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 was inclusive of a review of the leaflet and orifice dimensional matching data, which was found to be compliant and conforming with the established dimensional matching requirements.No changes to the spring mechanism for rotation were found to have been made, and the valve was not reprocessed or resterilized.The cause of the leaflet dislodgement could not be determined.

• Brand Name: SJM MASTERS SERIES VALVE EXPANDED CUFF
• 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: 9756609
• MDR Text Key: 180951416
• Report Number: 3003681312-2020-00007
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006453
• UDI-Public: 05414734006453
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2023
• Device Model Number: 27MECJ-502
• Device Catalogue Number: 27MECJ-502
• Device Lot Number: 6446628
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention; Disability