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

Model Number	PRT-25
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Migration or Expulsion of Device (1395); Perivalvular Leak (1457); Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2022
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
This report is for the 1st portico valve, prt-25, (b)(4) due to valve migration.It was reported that on (b)(6) 2022, a 25mm portico valve ((b)(4)) was chosen for implant for a transcatheter aortic valve replacement using a flexnav delivery system (8404696).The patient had a raphe type 1 bicuspid valve, and the raphe between the right coronary cusp and the non-coronary cusp was extremely calcified.The left ventricular outflow tract (lvot) was also smaller than the annulus.The patient had a very enlarged sinus, sinotubular junction (stj), and ascending aorta.The aortic annulus had a perimeter of 72mm.When the valve was deployed, the starting implant depth was 3mm on each side.The valve was re-sheathed more than two times, and the physician is aware of the instructions for use (ifu) warning against this.When the valve was released, the final implant depth was 3mm on each side.The valve did not expand due to the patient's unusual anatomy, and there was a perivalvular leak.The valve was very constrained, and the nose cone of the delivery system was leaning towards the outer curvature of the valve.When trying to remove the delivery system, the nose cone got caught on the valve, and the valve migrated up.The valve was not snared, and the patient remained stable at time of valve migration.A second 25mm portico valve (19047229) was chosen for a valve-in-valve procedure, using a second flexnav delivery system (8404696).When the second valve was deployed, the starting implant depth was 4mm on each side.There was no tension in the delivery system at the time of final deployment.The valve was re-sheathed more than two times, and the physician is aware of the ifu warning against this.When the second valve was released, the final implant depth was 4mm on each side.The second valve was also very constrained and had a perivalvular leak, and the raphe was pushing onto the device.A post-dilatation was performed multiple times, and the second 25mm portico valve migrated as well due to the post-dilatations.The second valve was not snared, and the patient remained stable at time of second valve migration.Neither migrated valve blocked a coronary artery or arteries.A third 25mm portico valve (19188503) was then successfully implanted using a third flexnav delivery system (8404696).The aortic gradient following the procedure was less than 10mmhg.Following the procedure, the patient went into rapid atrial fibrillation but was in stable condition overall.On (b)(6) 2022, the patient developed a complete heart block and passed away.Related manufacturer reference number: 2135147-2022-01065-00.
Additional Manufacturer Narrative
An event of the valve not expanding fully and migration was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications, including specifications for radial force.Information from the field indicated that the patient had unusual anatomy which constrained the valve.When the delivery system was removed from the patient, the nose cone hit the valve, which caused the device to migrate.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Please note, per the instructions for use "caution: do not re-sheath the valve more than two times.If additional positioning attempts are needed, completely resheath the valve and remove the valve from the patient.Use a new valve and delivery system to complete the procedure".

• Brand Name: PORTICO
• Common Device Name: 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: 15391272
• Report Number: 2135147-2022-01066
• Device Sequence Number: 6179246
• Product Code: NPT
• UDI-Device Identifier: 05415067012487
• UDI-Public: 05415067012487
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 11/29/2022

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: 08/31/2022
• Device Model Number: PRT-25
• Device Catalogue Number: PRT-25
• Device Lot Number: 7666884
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2022
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FLEXNAV DELIVERY SYSTEM, FNAV-DS-SM, 8404696
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female