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

Model Number	PRT-25
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Stroke/CVA (1770); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	06/01/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Literature article: aortic sinus contrast retention during tavr.As reported in a research article, mild regurgitation was noted after the portico valve was implanted and four hours after the implant procedure the patient had a stroke.The article concluded that as the stroke occurred immediately after the procedure, this suggested a procedure-related embolic origin.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.
Event or Problem Description
The article, "aortic sinus contrast retention during tavr", was reviewed.The research article presents a case study of a 73-year-old woman with severe aortic stenosis that was referred for aortic valve replacement with a 25mm portico valve.She had a history of severe chronic obstructive pulmonary disease, previous ischemic stroke, amyloid angiopathy-related cerebellar hemorrhage, permanent atrial fibrillation (af) with percutaneous left atrial appendage occlusion, and end-stage renal disease.Preprocedural ct showed moderate aortic valve calcification, with an aortic annulus perimeter of 69 mm and an area of 361 mm2 and a calcified sinotubular junction (stj).Final angiography showed mild residual aortic regurgitation, with dense contrast agent stagnation at the noncoronary sinus.Four hours later, the patient experienced right hemiparesis (4/5) and aphasia.Emergency head computerized tomography (ct) scan revealed occlusion of the left middle cerebral artery (m2 segment), and the patient underwent emergency thrombectomy with tici (thrombolysis in cerebral infarction) grade 2b partial recanalization.The patient developed hemorrhagic transformation and died 3 weeks after the procedure.The article concluded as the stroke occurred immediately after the procedure, this suggested a procedure-related embolic origin, with most acute (<24 hours) cerebrovascular events generally related to the procedure rather than to pre-existing comorbidities.Sinus contrast material retention after tavr is a rare phenomenon potentially translating to an increased thrombotic risk.The underlying etiologic factors may involve the virchow triad: endothelial injury or focal sinus dissection (after predilatation, during delivery system advancement, recapturing or repositioning maneuvers, pigtail entrapment), blood stasis (flow stagnation and reduced washout within the neosinus, a narrow or low stj), and hypercoagulability (older adult patients with cardiovascular risk factors).Observation of persistent contrast agent retention immediately after tavr may prompt close neurovascular monitoring and consideration for early anticoagulation and surveillance imaging to enable early recognition and management of ischemic complications.However, given the limited number of patients and other potential sources for cerebral emboli, these findings should be interpreted with caution and remain hypothesis generating.[the primary and corresponding author of this study is dabit arzamendi, interventional cardiology unit, hospital de la santa creu i sant pau, sant antoni m.Claret, 167, 08025 barcelona, spain with email: darzamendi@santpau.Cat].

• 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: 17200190
• Report Number: 2135147-2023-02751
• Device Sequence Number: 15120041
• Product Code: NPT
• UDI-Device Identifier: 05415067012487
• UDI-Public: 05415067012487
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2023

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 Model Number: PRT-25
• 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: 06/01/2023
• Initial Report FDA Received Date: 06/26/2023
• 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: Death
• Patient Age: 73 YR
• Patient Sex: Female