MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (CS-WOODRIDGE) PORTICO, TAVI, 29MM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number PRT-29

Device Problem Migration (4003)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2021

Event Type  Injury  

Event Description

It was reported that flexnav delivery system lg was selected to implant a 29mm portico valve on (b)(6) 2021.During the preparation, the valve capsule on the delivery system was unable to flushed and appeared clogged.Device did not come in contact with the patient.Device was replaced with a new delivery system.No patient harm was reported.It was also reported that during predilation with 23mm crystal balloon the patient became unstable.Resuscitation maneuver was done and the 29mm portico valve was release rapidly causing it to the migrate.The implant depth and final depth was between 3mm, and the sizing of the annular dimensions was min: 22/3, max: 29/3 and average 25/8 with an aortic angle angulation of 56 degrees.There was severe calcium to allow anchoring of the device and no tension in the delivery system at the time of final deployment.The physician did not snare and reposition valve.A second 29mm portico valves was implanted in the patient without harm.Patient is stable, there is no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

An event of valve migration after resuscitation of the patient was reported.A more comprehensive assessment could not be performed as a valve-in-valve was done so 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, 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: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12866585
• MDR Text Key: 281275708
• Report Number: 3007113487-2021-00088
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067012500
• UDI-Public: 05415067012500
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2024
• Device Model Number: PRT-29
• Device Catalogue Number: PRT-29
• Device Lot Number: 7825468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• 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