MAUDE Adverse Event Report: ABBOTT MEDICAL PORTICO; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number PRT-23

Device Problems Migration or Expulsion of Device (1395); Off-Label Use (1494)

Patient Problem Insufficient Information (4580)

Event Date 03/14/2022

Event Type  Death  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

This event is being reported due to the migration of the 23mm portico valve.It was reported that on (b)(6) 2022, a 23mm portico valve was chosen for implant into a 21mm non-abbott surgical valve.When the non-abbott guidewire was crossing the anatomy, the patient went into cardiac arrest.Cardiac massage was provided.The starting implant depth of the portico valve at deployment was 3-4mm, and the final implant depth at release was 3mm.The tension was completely removed in the delivery system at the time of final deployment.The patient had a normal aortic angle.The portico valve popped up.There was no interaction between the delivery system and the deployed valve, and there was no post-dilatation.The migrated valve did not block a coronary artery.The user repositioned the valve with a snare.A 20mm non-abbott valve was implanted within the first via a valve-in-valve procedure.The patient was in cardiac arrest for 45 minutes, and the patient recovered a rhythm before leaving the operating room.The cardiac arrest was believed to be due to the procedure itself and the patient condition, as the cardiac arrest occurred before the installation of the valve.The cardiac arrest is not related to the portico valve as it occurred prior to the valve being implanted.

Manufacturer Narrative

An event of the valve migrating after implant, cardiac arrest prior to the valve entering the patient and patient death due to intra-cranial hyper-tension due to the cardio-respiratory arrest was reported.A returned device assessment could not be performed as the device 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.Please note, per the instructions for use 'once the valve is fully deployed, repositioning and retrieval of the valve is not possible.Attempted retrieval (e.G., use of a guidewire, snare, or forceps) may cause aortic root, coronary artery, and/or myocardial damage." b2 - outcomes attributed to ae updated to reflect death.H1.Updated to death due to additional information.H6.Health effect - impact code - added code 1802 death.

Event Description

It was reported that on 14 march 2022, a 23mm portico valve was chosen for implant into a 21mm non-abbott surgical valve.When the non-abbott guidewire was crossing the anatomy, the patient went into cardiac arrest.Cardiac massage was provided.The starting implant depth of the portico valve at deployment was 3-4mm, and the final implant depth at release was 3mm.The tension was completely removed in the delivery system at the time of final deployment.The patient had a normal aortic angle.The portico valve migrated.There was no interaction between the delivery system and the deployed valve, and there was no post-dilatation.The migrated valve did not block a coronary artery.The user repositioned the valve with a snare.A 20mm non-abbott valve was implanted within the first via a valve-in-valve procedure.The patient was in cardiac arrest for 45 minutes, and the patient recovered a rhythm before leaving the operating room.The cardiac arrest was believed to be due to the procedure itself and the patient condition, as the cardiac arrest occurred before the installation of the valve.The cardiac arrest is not related to the portico valve as it occurred prior to the valve being implanted.Subsequent to the initially filed information, it was reported that the patient passed away on (b)(6) 2022 due to intercranial hypertension, which was due to cardiopulmonary arrest.

• Brand Name: PORTICO
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG#3007113487; 177 county road b east; st. paul MN 55117 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14072367
• MDR Text Key: 288983264
• Report Number: 2135147-2022-00143
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067010728
• UDI-Public: 05415067010728
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P190023
• 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: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2022
• Device Model Number: PRT-23
• Device Catalogue Number: PRT-23
• Device Lot Number: 8299979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2019
• 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
• Treatment: SAFARI S GUIDEWIRE (BOSTON SCIENTIFIC)
• Patient Outcome(s): Required Intervention; Death