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

Model Number	PRT-23
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	03/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Related manufacturer report number: 2135147-2023-01439.It was reported that on (b)(6) 2023, a 23mm portico valve was chosen for implant using a small flexnav delivery system.A balloon aortic valvuloplasty (bav) was performed the week prior.The patient's native annulus dimensions were as follows: min:16mm, max:24.4mm, average:20.2mm, peremater:62.7mm, area:288.9 mm2.The patient did not have a horizontal aorta.During the pre-procedure imaging, it was observed that the patient had a severely calcified st junction and femoral route.When attempting to place the device at the ideal depth, difficulty was encountered due to tortuous patient anatomy and the calcified aorta.When the device was 80% deployed, it was located 5-6mm below the non-coronary cusp and 7-8mm below the left coronary cusp.Immediately after the device was detached from the delivery system, it migrated about 2mm; there was no tension on the delivery system at the time of final deployment.The patient did not have a hypertensive spike at the time of migration and the migrated valve did not block a coronary artery.A mild to moderate perivalvular leak (pvl) around the left coronary cusp (lcc) was seen via angiogram.A post implant balloon aortic valvuloplasty (bav) was performed with a 20mm balloon to treat the pvl.During the post bav, the device migrated another 3mm and supra-skirtal leakage was observed.A second 23mm portico valve was then implanted using a new small flexnav delivery system.Both the post bav and second valve implant were considered emergent.The second valve was implanted at 3mm above the first valve.Again, a pvl around the lcc side was observed, and a post bav with a 23mm balloon was performed.The pvl was eliminated after the post bav was completed.The patient was hemodynamically unstable after the first valve was deployed but the transesophageal echo failed to show the leak location clearly.The physicians proceeded with post-dilatating the first valve, but the patient¿s vital signs were not improved.The physicians took some time to determine the cause of the hemodynamic crash which was mainly resulted from malpositioning of the valve.The second valve was prepared and deployed soon after the cause was confirmed and the patient resumed hemodynamically stability without significant change of heart wall motion.Of note, during procedure, the patient sustained complete atrioventricular (av) block.On (b)(6) 2023, a permanent pacemaker was implanted.The patient was reported as stable.
Additional Manufacturer Narrative
An event of perivalvular leak 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 specifications, including specification for radial force.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 or Problem Description
It was reported that on (b)(6) 2023, a 23mm portico valve was chosen for implant using a small flexnav delivery system.A balloon aortic valvuloplasty (bav) was performed the week prior.The patient's native annulus dimensions were as follows: min:16mm, max:24.4mm, average:20.2mm, peremater:62.7mm, area:288.9 mm2.The patient did not have a horizontal aorta.During the pre-procedure imaging, it was observed that the patient had a severely calcified st junction and femoral route.When attempting to place the device at the ideal depth, difficulty was encountered due to tortuous patient anatomy and the calcified aorta.When the device was 80% deployed, it was located 5-6mm below the non-coronary cusp and 7-8mm below the left coronary cusp.Immediately after the device was detached from the delivery system, it migrated about 2mm; there was no tension on the delivery system at the time of final deployment.The patient did not have a hypertensive spike at the time of migration and the migrated valve did not block a coronary artery.A mild to moderate perivalvular leak (pvl) around the left coronary cusp (lcc) was seen via angiogram.A post implant balloon aortic valvuloplasty (bav) was performed with a 20mm balloon to treat the pvl.During the post bav, the device migrated another 3mm and supra-skirtal leakage was observed.A second 23mm portico valve was then implanted using a new small flexnav delivery system.Both the post bav and second valve implant were considered emergent.The second valve was implanted at 3mm above the first valve.Again, a pvl around the lcc side was observed, and a post bav with a 23mm balloon was performed.The pvl was eliminated after the post bav was completed.The patient was hemodynamically unstable after the first valve was deployed but the transesophageal echo failed to show the leak location clearly.The physicians proceeded with post-dilatating the first valve, but the patient¿s vital signs were not improved.The physicians took some time to determine the cause of the hemodynamic crash which was mainly resulted from malpositioning of the valve.The second valve was prepared and deployed soon after the cause was confirmed and the patient resumed hemodynamically stability without significant change of heart wall motion.Of note, during procedure, the patient sustained complete atrioventricular (av) block.On (b)(6) 2023, a permanent pacemaker was implanted.The patient was reported as stable.(b)(6): first valve; (b)(6): second valve.

• Brand Name: PORTICO TRANSCATHETER AORTIC VALVE
• Common Device Name: 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: 16657670
• Report Number: 2135147-2023-01440
• Device Sequence Number: 20642331
• Product Code: NPT
• UDI-Device Identifier: 05415067010728
• UDI-Public: 05415067010728
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/08/2026
• Device Model Number: PRT-23
• Device Catalogue Number: PRT-23
• Device Lot Number: 8859732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 65 KG