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

Model Number PRT-25

Device Problems Migration or Expulsion of Device (1395); Separation Problem (4043)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2022, a 25mm portico valve ((b)(4)) was chosen for procedure, along with a small flexnav delivery system (7912796).During procedure, the implanter aimed at a depth of 3mm below the non-coronary cusp on the cusp-overlapping projection.While the valve was being slowly deployed and reached the 80% safety lock, the valve depth was verified.The implant depth was confirmed to be 3mm below the non-coronary cusp and 2mm below the left-coronary cusp.It was noted that there was severe calcification over the left ventricular out flow tract.During the final phase of deployment, the deployment wheel was turned to the deployment end with audio feedback, but one retainer tab that was not able to detach from the delivery system.The delivery system was turned clockwise/counter-clockwise about 90 degrees but without success.The non-abbott guidewire was then retracted, and the retainer tab was confirmed detaching from the delivery system.There was no tension in the delivery system at the time of final deployment, and the patient did not have an acute aortic angle.The delivery system was safely removed.The pigtail catheter was repositioned with soft wire to the aortic stent of the portico valve, and the aortogram showed the valve popped up a bit with supra-annular position over the non-coronary cusp (ncc) and 1mm below the left coronary cusp (lcc).The valve then further shifted toward the ascending aorta.There was no inference with any coronary arteries.While the patient's blood pressure remained stable, a second 25mm portico valve ((b)(4)) was quickly prepared along with a second small flexnav delivery system (7967498).The second valve was deployed inside the first at a depth of 7mm below ncc and 5mm below lcc.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

An event of the valve migrating towards ascending aorta after implant was reported.A returned device 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 defined manufacturing specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

Event Description

N/a.

• 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: 13996588
• MDR Text Key: 288793428
• Report Number: 2135147-2022-00122
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 05415067012487
• UDI-Public: 05415067012487
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2024
• Device Model Number: PRT-25
• Device Catalogue Number: PRT-25
• Device Lot Number: 7825466
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2022
• 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
• Treatment: FLEXNAV DELIVERY SYSTEM, FNAV-DS-SM, 7912796.; SAFARI PRE-SHAPED GUIDEWIRE (BOSTON SCIENTIFIC).
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 46 KG