MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (CS-WOODRIDGE) SJM REGENT HEART VALVE W/FLEX CUFF; HEART-VALVE, MECHANICAL

Model Number 21AGFN-756

Device Problems Fracture (1260); Difficult To Position (1467)

Patient Problems Death (1802); Exsanguination (1841)

Event Date 12/11/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.This mdr is related to (b)(4) for the first valve (serial (b)(4)).

Event Description

The patient presented with acute aortic insufficiency secondary to aortic valve endocarditis and had a history of severe pulmonary hypertension (systemic pap).Intra-operatively findings included an annular abscess, a bicuspid native aortic valve and absence of the right coronary commissure.The abscess was evacuated and the native valve was debrided.A pericardial patch was used for reconstruction.A 23mm valve was recommended based on annulus measurements; however the physician opted to implant a 21mm regent mechanical heart valve (serial (b)(4)).The leaflets were not moving as freely as expected and the physician attempted to rotate the valve; however, despite multiple attempts and the use of a clamp, the valve would not rotate.The 21mm regent valve was removed, an aortic root enlargement was performed and a second 21mm regent valve was placed (serial (b)(4)).When implanting the second 21mm valve, it was rotated 45 degrees prior to placement but it was not sufficient and again, attempts to rotate the valve were unsuccessful.A clamp was used which resulted in a leaflet fracture and the second 21mm valve was removed.A 19mm regent valve (serial (b)(4)) was successfully implanted at a 90 degree rotation relative to the first valve; however, the patient developed a pulmonary hemorrhage and expired.Ex vivo, one of the regent valves was inspected and could not be rotated by the physician.The physician reported extended pump time contributed to the patient's death.

• Brand Name: SJM REGENT HEART VALVE W/FLEX CUFF
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (CS-WOODRIDGE); 177 east county road b; st. paul MN 55117
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5358058
• MDR Text Key: 35638064
• Report Number: 3007113487-2016-00005
• Device Sequence Number: 1
• Product Code: LWQ
• 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: 12/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/20/2019
• Device Model Number: 21AGFN-756
• Device Catalogue Number: 21AGFN-756
• Device Lot Number: 4573452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2014
• 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
• Patient Outcome(s): Death
• Patient Age: 37 YR