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 Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024)

Event Date 07/12/2012

Event Type  Injury  

Manufacturer Narrative

Citation: lurz p et al.Impact of reduction in right ventricular pressure and/or volume overload by percutaneous pulmonary valve implantation on biventricular response to exercise: an exercise stress real-time cmr study.Eur heart j.2012 oct;33(19):2434-41.Doi: 10.1093/eurheartj/ehs200.Epub 2012 jul 12.Earliest date of publish used for event date in.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding the use of real-time cardiac magnetic resonance imaging to evaluate potential differences in biventricular response to exercise in patients with pulmonary stenosis and pulmonary regurgitation pre- and post- percutaneous pulmonary valve implantation.The study population included 17 patients (predominantly male; mean age 19 years; mean weight 62 kg), 2 of which were previously implanted with medtronic hancock valved conduits (no serial numbers provided).Among all patients, adverse events included: pulmonary stenosis (with high right ventricular outflow tract mean gradients) or pulmonary regurgitation requiring percutaneous pulmonary valve implantation.Based on the available information, medtronic product may have been 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: 8680772
• MDR Text Key: 147440526
• Report Number: 2025587-2019-01865
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• 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: 05/20/2019
• 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: 19 YR
• Patient Weight: 62