MAUDE Adverse Event Report: ABBOTT MEDICAL UNKNOWN MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Catalog Number UNK MECHANICAL HEART VALVE

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Aortic Valve Stenosis (1717); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 08/15/2023

Event Type  Death  

Manufacturer Narrative

B2 - date of death is estimated.D4 - the udi number is not known as the part and lot numbers were not provided.An event of prosthetic valve thrombosis and death was reported through a research article.Information from the field indicated that device related thrombus was initially treated with medication but the patient was non-compliant which resulted in repeat aortic thrombus that led to cardiogenic shock.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or additional patient information was received for analysis.Based on the available information, the root cause of the prosthetic valve thrombosis and central regurgitation could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

Event Description

The article, "dual mechanical valve thrombosis resolution through thrombolytics: a case series", was reviewed.The article presented a case study of a 52-year-old female with dyspnea, intermittent chest pain, history of severe rheumatic mitral and aortic stenosis, history of congestive heart failure with preserved ejection fraction, and multiple ischemic strokes with hemorrhagic conversion.It was reported on an unknown date, a 21mm unknown st.Jude mechanical aortic valve was implanted along with concomitant 31mm non-abbott mechanical mitral valve and 30mm non-abbott tricuspid valve repair.It was reported on an unknown date approximately 3 years post-procedurally, a follow up trans-thoracic echocardiogram (tte) noted moderate prosthetic aortic regurgitation, severe prosthetic aortic valve stenosis with visualized 11x5 mm intra-valvular thrombus and elevated mean trans-valvular gradient.The patient was administered low-dose ultra-slow infusions of tissue plasminogen activator (tpa) with interval re-initiation of a therapeutic unfractionated heparin drip.It was reported leaflet mobility showed improvement and was transitioned to warfarin and discharged in stable conditions.The patient was represented 5 months later in cardiogenic shock due to repeat aortic thrombus from sub-therapeutic inr secondary to medication non- compliance.The patient was reported to have passed away from this episode on an unknown date.The article concluded that dual mechanical pvt is a rare but serious complication of mechanical valve replacement, and its management should include multi-disciplinary discussion individualized to each patient¿s unique risk factors.Patients with obstructive symptoms and high surgical risk or who opt for medical therapy should undergo thrombolysis.Low-dose and slow or ultra-slow tpa infusion should be considered for those with high bleeding risk and can be safe even with elevated inr.Thrombosis may continue to resolve over weeks after thrombolysis, and percutaneous intervention may be considered for refractory valve dysfunction.[the primary author was colin mcguire, department of medicine, georgetown university hospital, washington, dc, usa.The corresponding author was benjamin kenigsberg, division of cardiology, medstar washington hospital center, 110 irving st., nw, washington, dc, usa, with corresponding email: benjamin.B.Kenigsberg@medstar.Net].

• Brand Name: UNKNOWN MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17843477
• MDR Text Key: 324587421
• Report Number: 2135147-2023-04242
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK MECHANICAL HEART VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 52 YR
• Patient Sex: Female