MAUDE Adverse Event Report: ST. JUDE MEDICAL CANADA, INC. SJM TORONTO SPV TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number SPA-101-25

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/27/2020

Event Type  Injury  

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 an unknown date a 25mm sjm® toronto spv® tissue valve was implanted.On (b)(6) 2020, a valve in valve was performed and a 25mm portico tavi valve was selected for implant.During deployment, the device was released too high, and increase aortic regurgitation was noted.A second 25mm portico tavi valve was selected, and deployed successfully.The patient was reported to be in stable condition.

Manufacturer Narrative

An event of valve in valve performed within the toronto valve was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SJM TORONTO SPV TISSUE VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL CANADA, INC.; 2550 blvd. vanier; st. hyacinthe J2S 6 L7; CA J2S 6L7
• MDR Report Key: 10829135
• MDR Text Key: 215913430
• Report Number: 8020430-2020-00001
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P970030
• 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: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPA-101-25
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR