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

Model Number CONTEGRA

Device Problems Calcified (1077); Gradient Increase (1270)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 12/05/2017

Event Type  Injury  

Manufacturer Narrative

Citation: hascoet s percutaneous pulmonary valve implantation in small conduits: a multicenter experience.Int j cardiol.2018 mar 1;254:64-68.Doi: 10.1016/j.Ijcard.2017.12.003.Epub 2017 dec 5.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 multi-center experience on percutaneous pulmonary valve implantation in small conduits.All data were collected from multiple centers between may 2008¿july 2016.The study population included 14 patients (mean age 12 years), all of whom were implanted with medtronic melody device; 3 patients had been previously implanted with contegra pulmonary valved conduit.The serial numbers were not provided.Among all patients adverse events included: mild pulmonary valve regurgitation.Based on the available information, this adverse event can be attributed to medtronic product.No additional adverse patient effects or product performance problems 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: 7316302
• MDR Text Key: 101596207
• Report Number: 2025587-2018-00489
• Device Sequence Number: 1
• Product Code: MWH
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Health Professional
• Type of Report: Initial
• Report Date: 03/05/2018

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: 02/27/2018
• Initial Date FDA Received: 03/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR
• Patient Weight: 45