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

Catalog Number	PRT-25
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The article, "emergent conversion to open heart surgery during transcatheter aortic valve implantation: the presence of a rescue team improves outcomes", was reviewed.The article presented a case study of an 85-year-old male with diabetes, arterial hypertension, and mild renal failure.It was reported that on an unknown date, a 25mm navitor valve was chosen for implant.During procedure, there was a perforation caused by positioning of a stiff unknown guidewire and the patient experienced cardiogenic shock and cardiac arrest.After the patient was stabilized, a cardiopulmonary bypass was required to support the transcatheter aortic valve implant procedure.After implant, it was noted there was mild paravalvular leak and the patient was administered three units of blood transfusion.The patient status was reported stable and discharged home after 18 days.The article concluded that surgical treatment is rare during tavi.The presence of an expert complete rescue team as support means an increase in survival.Surgery must be used only to restore circulatory and to treat complication while percutaneous approaches should complete the procedure.[the primary and corresponding author was (b)(6).
Additional Manufacturer Narrative
B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided.As reported in a research article, a mild paravalvular leak was noted after device implant.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.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 regards to manufacture, design, or labeling.

• 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: 18470288
• Report Number: 2135147-2024-00146
• Device Sequence Number: 6924021
• Product Code: NPT
• UDI-Device Identifier: 05415067012487
• UDI-Public: 05415067012487
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/08/2024

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 Catalogue Number: PRT-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 85 YR
• Patient Sex: Male