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

Model Number HC150-12

Device Problem Insufficient Information (3190)

Patient Problems Pulmonary Valve Stenosis (2024); Obstruction/Occlusion (2422)

Event Date 01/27/2019

Event Type  Injury  

Manufacturer Narrative

Citation: lee wy et al.Surgical options for pulmonary atresia with ventricular septal defect in neonates and young infants.Pediatr cardiol.2020 jun;41(5):1012-1020.Doi: 10.1007/s00246-020-02352-9.Epub 2020 may 6.Presented at the 55th annual meeting of society of thoracic surgeons, san diego, ca, january 27¿29, 2019.Earliest date of presentation used for date of event.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 return of the product no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from a literature article regarding the impact of surgical strategies on overall survival and the incidence of post-repair re-interventions in patients with pulmonary atresia with ventricular septal defect who underwent staged repair or primary repair.All data were retrospectively collected from a single center between 2004 and 2017.The study population included 65 pediatric patients.Of those, 25 were implanted with medtronic valved conduits: contegra (16) and hancock (9).No serial numbers were provided.Among all patients, 6 early and 4 inter-stage deaths occurred, respectively.The study used non-medtronic conduits, tube grafts, and unspecified miscellaneous repair products in addition to the contegra and hancock.The type of conduit implanted in each patient who died was not reported.Based on the available information, medtronic product was not directly associated with the deaths.Among all patients, adverse events included surgical and catheter-based re-interventions.Surgical re-interventions performed: conduit replacement; peel operation using the back wall of previous conduit; right ventricular outflow tract obstruction relief; and branch pulmonary artery angioplasty.Catheter-based re-interventions performed: ballooning/stenting of the conduit; ballooning/stenting of branch pulmonary artery stenosis; and ballooning of the superior vena cava.Other adverse events reported: long post-operative ventilatory support and aneurysmal dilatation of a contegra conduit.Based on the available information, medtronic product was associated with the adverse events.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: 10382531
• MDR Text Key: 202695599
• Report Number: 2025587-2020-02544
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P790007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: Yes
• 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: 07/15/2020
• 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