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

Model Number 29VAVGJ-515

Device Problem Obstruction of Flow (2423)

Patient Problem Aortic Valve Stenosis (1717)

Event Date 05/12/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported on 12 may, 2021, a sjm masters series valsalva aortic valve graft, mechanical heart valve was chosen for procedure.The device was implanted and functioning properly.Post implant, a transesophageal echocardiogram (echo) was performed revealing the opening angle of the valve was significantly reduced.No external or sub-valvular obstructions were observed and no calcification was present.A decision was made to re-operate the same day.The valve was rotated 90 degrees.This maneuver had fixed the problem and re-established the opening angle of the leaflets.A 5 mmhg gradient was confirmed and the valve was functioning properly.The patient is recovering and stable.The cause of the problem remains unknown.No additional information was provided (27may21,pm).

Manufacturer Narrative

An event of the opening angle of the valve being decreased so the valve was rotated which fixed the problem was reported.A more comprehensive assessment could not be performed as the device remains implanted was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SJM MASTERS SERIES VALSALVA AORTIC VALVED GRAFT
• 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: 11965914
• MDR Text Key: 255104795
• Report Number: 2648612-2021-00053
• Device Sequence Number: 1
• Product Code: LWQ
• 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: 07/07/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 29VAVGJ-515
• Device Catalogue Number: 29VAVGJ-515
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/12/2021
• Initial Date FDA Received: 06/09/2021
• Supplement Dates Manufacturer Received: 06/21/2021
• Supplement Dates FDA Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention