MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA PORTICO, TAVI, 29MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number PRT-29

Device Problems Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 02/07/2022

Event Type  Injury  

Event Description

It was reported on (b)(6) 2022, a 29mm portico, tavi valve was selected for implant.After releasing the valve, it "popped-up" and the valve moved and was positioned above the annulus 2-3mm from the intra-annular position that was desired.Do to the valve migration an aortic leak was noted and a non-abbott valve was implanted.The initial valve was snared back into place.There was sufficient calcium to allow anchoring for the valve and there was no tension reported when deploying the valve.When deploying the valve was pulled slightly in the ring but otherwise no issues with deployment.The patient had a horizontal aorta and the patient's annular dimensions are unknown and cannot be provided.The patient was reported to be in stable condition.Operative notes and echo images were requested but cannot be provided.

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

It was reported on (b)(6) 2022, a 29mm portico, tavi valve was selected for implant.After releasing the valve, it "popped-up" and the valve moved and was positioned above the annulus 2-3mm from the intra-annular position that was desired.Do to the valve migration an aortic leak was noted and a non-abbott valve was implanted.The initial valve was snared back into place.There was sufficient calcium to allow anchoring for the valve and there was no tension reported when deploying the valve.When deploying the valve was pulled slightly in the ring but otherwise no issues with deployment.The patient had a horizontal aorta and the patient's annular dimensions are unknown and cannot be provided.The patient was reported to be in stable condition.Operative notes and echo images were requested but cannot be provided.

Manufacturer Narrative

An off label event of snaring of a 29mm portico tavi valve after initial implantation of the valve in an undesired position was reported.A more comprehensive assessment could not be performed as the device remains implanted and 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.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: PORTICO, TAVI, 29MM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13585442
• MDR Text Key: 286051042
• Report Number: 3005334138-2022-00145
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067012500
• UDI-Public: 05415067012500
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: G120263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PRT-29
• Device Catalogue Number: PRT-29
• Device Lot Number: 8264691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/24/2021
• 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): Required Intervention