MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION VALVE CONTEGRA; CONDUIT,VALVED,PULMONIC

Model Number CONTEGRA

Device Problems Calcified (1077); Obstruction of Flow (2423)

Patient Problems Calcium Deposits/Calcification (1758); Pulmonary Valve Stenosis (2024); Vascular System (Circulation), Impaired (2572)

Event Date 02/12/2013

Event Type  Injury  

Manufacturer Narrative

Citation: boshoff de et al.Off-label use of percutaneous pulmonary valved stents in the right ventricular outflow tract: time to rewrite the label? catheter cardiovasc interv.2013 may;81(6):987-95.Doi: 10.1002/ccd.24594.Epub 2013 feb 12.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding the safety and feasibility of off-label application of percutaneous pulmonary valve implantation (ppvi).All data were collected from a single center between november 2006 and february 2012.The study population included 23 patients (mean age 17 years; mean weight 42 kg), 21 of which were implanted with a medtronic melody bioprosthetic valve and 5 were previously implanted with medtronic contegra valved conduit.No serial numbers were provided.Among all patients, adverse events included: pulmonary conduit stenosis and/or regurgitation requiring ppvi, right ventricular outflow tract obstruction/calcification, 1 case (patient 1) of progressive stenosis due to a muscular band below the valve after regression of right ventricle dilation requiring surgical intervention, and 1 case (patient 19) of increased peak instantaneous gradient across the right ventricular outflow tract due to patient growth and small valve size, but it was reported that no intervention occurred as a result.Multiple manufacturers were noted in the literature; however, based on the available information, medtronic product may have caused or contributed to these adverse events.No additional adverse patient effects or product performance issues were reported.

• Brand Name: VALVE CONTEGRA
• Type of Device: CONDUIT,VALVED,PULMONIC
• 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: 8139842
• MDR Text Key: 129567413
• Report Number: 2025587-2018-03331
• Device Sequence Number: 1
• Product Code: MWH
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: H020003
• 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: 12/06/2018

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: CONTEGRA
• Device Catalogue Number: CONTEGRA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2018
• Initial Date FDA Received: 12/06/2018
• 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: 17 YR
• Patient Weight: 42