MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number T505

Device Problem Insufficient Information (3190)

Patient Problems Aortic Valve Stenosis (1717); Arrhythmia (1721); Non specific EKG/ECG Changes (1817); Ventricular Tachycardia (2132)

Event Date 05/30/2017

Event Type  Injury  

Manufacturer Narrative

Citation: gallotti et al.Subvalvular catheter ablation of the cavotricuspid isthmus in a patient with ebstein¿s anomaly and tricuspid valve replacement.Heartrhythm case reports.2017 may 30;3(7):336-339.Doi: 10.1016/j.Hrcr.2017.04.008.Ecollection 2017 jul.Earliest date of publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a (b)(6)-year-old male patient with ebstein¿s anomaly who underwent implant of a medtronic hancock porcine valve (serial number not provided) in the tricuspid position.Approximately 4 years later, the patient developed symptomatic intra-atrial reentrant tachycardia (iart).A computed tomography (ct) angiography showed the valve was at the level of the true atrioventricular valve annulus with the right coronary artery coursing along its perimeter.At the age of 27 years, the patient underwent a catheter ablation procedure that turned out to be ineffective.The patient continued to experience episodes of atrial flutter requiring synchronized cardioversion multiple times per year, and subsequently developed bioprosthetic valve stenosis in the setting of depressed right ventricular (rv) systolic function.At the age of 36 years, the patient underwent catheter ablation and a transcatheter tricuspid valve replacement with a non-medtronic valve.At the end of the case there were no inducible arrhythmias.At 8 months post-procedure, the patient remained free from tachycardia recurrence.The etiology of the rv dysfunction was unclear, but was suspected to be due to irreversible rv remodeling from many years of tricuspid regurgitation in combination with repeated episodes of atrial tachycardia.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the physician/author stated medtronic product did not cause or contribute to the observed adverse events, no model/serial numbers were available, and the patient's weight ((b)(6) pounds).

• Brand Name: HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7140295
• MDR Text Key: 95582796
• Report Number: 2025587-2017-02534
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: T505
• Device Catalogue Number: T505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 12/22/2017
• Supplement Dates FDA Received: 12/22/2017
• 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): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 89