MAUDE Adverse Event Report: HEART VALVES SANTA ANA VALVE CONTEGRA; CONDUIT,VALVED,PULMONIC

Model Number CONTEGRA

Device Problem Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 09/15/2016

Event Type  Injury  

Manufacturer Narrative

Citation: góreczny s et al.Investigating the purview of melody valve implantation for the pediatric population - an alluring option.Polish heart journal.2016; 74 (15-17).Presented at the 20th international congress of the polish cardiac society 15¿17 september 2016.Date of presentation 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.

Event Description

Medtronic received information via literature regarding percutaneous pulmonary valve implantation outcomes in pediatric patients implanted with a melody bioprosthetic valve.All data were collected from a single center between april 2012 and march 2016.The study population included 19 patients (mean age 13.6 years, mean weight 46 kg), all of which were implanted with a medtronic melody bioprosthetic valve (serial numbers not provided).Among all 19 patients adverse events included: 1 immediate stent fracture and 2 groin hematoma.During follow-up echocardiography showed stable right ventricular outflow tract velocity with nothing more than mild pulmonary regurgitation in all patients.Additionally, 4 of the 19 patients had a previously implanted medtronic contegra conduit (serial numbers not provided) with noted dysfunction which was addressed with implant of a melody valve.No further details were provided.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALVE CONTEGRA
• Type of Device: CONDUIT,VALVED,PULMONIC
• Manufacturer (Section D): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): HEART VALVES SANTA ANA; 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: 6524716
• MDR Text Key: 73780198
• Report Number: 2025587-2017-00691
• Device Sequence Number: 1
• Product Code: MWH
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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,Followup
• Report Date: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• 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
• Date Manufacturer Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 14 YR
• Patient Weight: 46