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

Model Number	PRT-23
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Expiration Date Error (2528)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	10/26/2016
Type of Reportable Event	Death
Event or Problem Description
Clinical information: crd_1025 - portico valve-in-valve retrospective registry, patient site id: (b)(6).It was reported that on (b)(6) 2016, a 23mm portico valve was implanted using a flexnav delivery system during a valve-in-valve procedure.The portico valve was implanted into a previously implanted 23mm non-abbott valve.The route for the transcatheter aortic valve replacement was the right transfemoral artery.Following the implant of the valve, the tavr access route was closed using an angio-seal closure device.The non-tavr access site on the right side was closed with a prostar closure device.2 sutures were also placed.On (b)(6) 2016, there was bleeding at the access point from the right groin and clopidogrel treatment was paused.Over the next two days there was swelling and a hematoma in the left groin, and the scrotum became swollen.Pain medication was increased.There was no suspicion of bacterial infection.On (b)(6) 2016, the patient was discharged.On (b)(6) 2016, the patient passed away due to heart failure.On the label of the 23mm portico valve, the expiration date was listed as 18 february 2017 instead of 19 february 2016.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of bleeding at the access point from the right groin while delivery system was mobilizing in the patient, swelling and a hematoma in the left groin, swollen scrotum and patient death due to heart failure was reported.The patient's medical history included aortic valve replacement, coronary artery disease, coronary artery bypass graft, hyperlipidemia and hypertension.Based om information received from field, there was no blood transfusion required and there was no suspicion of bacterial infection.Field indicated that pain medication was increased.A returned device assessment could not be performed as the device remained 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.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.Information from field indicated that the portico valve was implanted into a previously implanted 23 mm non-abbott valve.Please note that per the instructions for use, "the portico¿ valve, shown below (page 2), is designed to be implanted in the native aortic heart valve without open heart surgery and without concomitant surgical removal of the failed native valve.".
Additional Manufacturer Narrative
An event of bleeding at the access point from the right groin while delivery system was mobilizing in the patient, swelling and a hematoma in the left groin, swollen scrotum and patient death due to heart failure was reported.The patient's medical history included aortic valve replacement, coronary artery disease, coronary artery bypass graft, hyperlipidemia and hypertension.Based om information received from field, there was no blood transfusion required and there was no suspicion of bacterial infection.Field indicated that pain medication was increased.A returned device assessment could not be performed as the device remained 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.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.Information from field indicated that the portico valve was implanted into a previously implanted 23 mm non-abbott valve.Please note that per the instructions for use, artmt600115937 - a, "the portico valve was implanted into a previously implanted 23mm non-abbott valve.Correction: d4.
Event or Problem Description
Clinical information: (b)(6).It was reported that on (b)(6) 2016, a 23mm portico valve was implanted using a flexnav delivery system during a valve-in-valve procedure.The portico valve was implanted into a previously implanted 23mm non-abbott valve.The route for the transcatheter aortic valve replacement was the right transfemoral artery.Following the implant of the valve, the tavr access route was closed using an angio-seal closure device.The non-tavr access site on the right side was closed with a prostar closure device.2 sutures were also placed.On(b)(6) 2016, there was bleeding at the access point from the right groin and clopidogrel treatment was paused.Over the next two days there was swelling and a hematoma in the left groin, and the scrotum became swollen.Pain medication was increased.There was no suspicion of bacterial infection.On (b)(6) 2016, the patient was discharged.On (b)(6) 2016, the patient passed away due to heart failure.

• 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): 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: 16796701
• Report Number: 2135147-2023-01775
• Device Sequence Number: 3138967
• Product Code: NPT
• UDI-Device Identifier: 05415067010728
• UDI-Public: 05415067010728
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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,Followup
• Report Date (Section B): 06/28/2023

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: 02/18/2017
• Device Model Number: PRT-23
• Device Catalogue Number: PRT-23
• Device Lot Number: 5402336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 05/31/2023; 06/06/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 06/01/2023; 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2015
• 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: Death
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White