MAUDE Adverse Event Report: ABBOTT MEDICAL PORTICO; 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 Cardiac Arrest (1762)

Event Date 12/12/2022

Event Type  Death  

Event Description

It was reported that on (b)(6) 2022, a 29mm portico valves was selected for an implant.The implanters stated the leaflets and annulus was heavily calcified, unsure of the calcium score.The annular perimeter derived = 26.1mm and the patient did not have a horizontal aorta.During deployment, the valve migration to the point of the sinotubular junction (stj).On initial placement it was slightly high (0mm on the non-coronary cusp (ncc) and 2mm on the left-coronary cusp (lcc)) and after a few cardiac cycles, the valve migrated.The valve was snared to the ascending aorta and a valve in valve procedure was performed with a non-abbott device which was expandable and consequently ruptured the aortic root on deployment.After 1 hour of cardiopulmonary resuscitation (cpr).The patient passed away.The cause of death is annular rupture due to bail out balloon expandable valve placed port embolization of portico valve.The implanter stated that he had no issue with the portico valve used but as it had migrated, he felt more comfortable and quicker at using the non-abbott balloon expandable valve as a bail out option- this was too big for the annulus/ lvot and ruptured the aortic root, subsequently causing the patient's decline in condition.No additional information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

An event of the valve migrating during the procedure and patient death was reported.The possible causes of migration include calcification, acute aortic angle, the tension in the delivery system, and the valve getting caught in the delivery system.Information from the field indicated that the final implant depth was 0mm on the ncc and 2mm on lcc, there was no tension in the delivery system, and there was no interaction between the delivery system and the deployed valve.The field indicated that the leaflets and annulus were heavily calcified.Information from the field indicated that the portico valve was implanted high and the valve embolized into a sinotubular junction after a few cardiac cycles; the embolized portico valve was snared.A valve-in-valve procedure was performed with a non-abbott (edwards balloon-expandable valve) device.The edwards balloon expandable valve was big for the patient annulus/ lvot and ruptured the aortic root causing the death of the patient.Abbott requested information related to procedure imaging, but this was not provided.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 including the valve meeting stent radial force specifications, and the product met all specifications.Based on the information received, the cause of the patient's death was the use of a non-abbott valve which ruptured the patient's annulus leading to the death, and was not related to the abbott products used.Please note, per the portico tavi valve instructions for use, "post-implantation precautions: once the valve is fully deployed, repositioning and retrieval of the valve are not possible.Attempted retrieval (e.G., use of a guidewire, snare, or forceps) may cause aortic root, coronary artery, and/or myocardial damage.

Event Description

It was reported that on (b)(6) 2022 a 29 mm portico valve was selected for implant in a patient whose native leaflets and annulus were heavily calcified.The patient¿s anatomy was significant for a ¿septal bulge¿ presumably involving the basal interventricular septum.During deployment, the valve was re-sheathed one time.The device was implanted high with an implant depth of 0 mm at the non-coronary cusp and 2 mm at the left coronary cusp.After a few cardiac cycles, the valve embolized out of the annulus and into the aorta to the level of the sino-tubular junction.The valve did not block coronary arteries.The valve was snared into the ascending aorta.The physician elected to rapidly prep and deploy an unknown size non-abbott valve.Immediately after deployment of the non-abbott device, an annular rupture was noted.Although the non-abbott device size was not provided to abbott, the physician indicated the valve was too large for the patient¿s anatomy.The patient became hemodynamically unstable.The patient underwent resuscitative efforts including cardiopulmonary resuscitation (cpr) for approximately one hour, however, these efforts were not successful and the patient passed away the same day.

• 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): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16114197
• MDR Text Key: 306822209
• Report Number: 2135147-2023-00075
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067012500
• UDI-Public: 05415067012500
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2024
• Device Model Number: PRT-29
• Device Catalogue Number: PRT-29
• Device Lot Number: 7927943
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2021
• 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): Death
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 84 KG