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

Model Number HC150-12

Device Problems Gradient Increase (1270); Obstruction of Flow (2423)

Patient Problems Arrhythmia (1721); Atrial Fibrillation (1729); Non specific EKG/ECG Changes (1817); Pulmonary Regurgitation (2023); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132); Stenosis (2263); Low Cardiac Output (2501); Complete Heart Block (2627)

Event Date 03/01/2019

Event Type  Injury  

Manufacturer Narrative

Citation: huang es et al.Rastelli operation for d-transposition of the great arteries, ventricular septal defect, and pulmonary stenosis.World j pediatr congenit heart surg.2019 mar 1;10(2):157-163.Doi: 10.1177/2150135118817765.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.Without the return of the product, no definitive conclusion can be made regarding the clinical observations.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding an evaluation of the long-term follow-up of patients who underwent the rastelli operation for dextro-transposition of the great arteries, ventricular septal defect, and pulmonary stenosis or pulmonary atresia.All data were collected and retrospectively reviewed from a single center between 1988 and 2017.The study population included 47 patients (predominantly male; mean age 3 years; mean weight 16 kg), 18 of which were implanted with a medtronic contegra valved conduit, 1 was implanted with a medtronic freestyle bioprosthesis, and 1 was implanted with a medtronic hancock valved conduit (no serial numbers provided).The literature characterized early mortality as ¿death during initial hospitalization or within 30 days of operation¿ and late mortality as ¿any deaths beyond 30 days after the initial rastelli operation and after discharge.¿ among all patients, 4 deaths occurred (1 early, 3 late).Multiple manufacturers were noted in the literature; based on the available information, medtronic product was not directly associated with the death(s).Among all patients, adverse events included: permanent pacemaker implantation (due to intermittent atrioventricular block, third-degree atrioventricular block, subaortic stenosis, sick sinus syndrome, atrial and ventricular fibrillation, complete heart block, first-degree atrioventricular delay, and right bundle branch block), early reoperation due to low cardiac output, subaortic stenosis resection/conduit replacement, conduit replacement/reintervention due to right ventricular outflow tract obstruction identified as either stenosis or pulmonary regurgitation, catheter-based conduit reintervention (balloon angioplasty, stent placement, and transcatheter pulmonary valve implant), catheter ablation for atrial tachycardia and left bundle branch morphology for ventricular tachycardia, cardiac transplantation, bacterial endocarditis (1 contegra case), moderate pulmonary regurgitation, mild left ventricular outflow tract obstruction, moderate conduit stenosis, and increased peak systolic gradients.Based on the available information, medtronic product may have been associated with the adverse event(s).No additional adverse patient effects or product performance issues were reported.

• Brand Name: HANCOCK
• 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: 8542598
• MDR Text Key: 142910151
• Report Number: 2025587-2019-01326
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P790007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HC150-12
• Device Catalogue Number: HC150-12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2019
• 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: 3 YR
• Patient Weight: 16