MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION CONTEGRA PULMONARY VALVED CONDUIT - SUPPORTED; CONDUIT,VALVED,PULMONIC

Model Number 200S

Device Problem Calcified (1077)

Patient Problems Aneurysm (1708); Endocarditis (1834); Pulmonary Valve Stenosis (2024); Pulmonary Valve Insufficiency/ Regurgitation (4452)

Event Date 01/01/2011

Event Type  Injury  

Manufacturer Narrative

Citation: dave, h.Et al.Risk factor analysis of 170 single-institutional contegra implantations in pulmonary position.Ann thorac surg 2011;91:195¿203.Doi: 10.1016/j.Athoracsur.2010.07.058.Earliest date of publish used for event date.Medtronic products referenced: contegra pulmonary valved conduit (pma# h020003, product code mwh).Earliest approved product used for product code and pma#.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 via literature regarding risk factor analysis of contegra implantations.All data were collected from a single center between 2001 and 2007.The study population included 170 patients (predominantly male, mean age 9 years), all of whom were implanted with medtronic contegra valved conduit.No serial numbers were provided.Among all contegra patients, adverse events included: stenosis, increased gradient measurements, severe regurgitation, calcification, outgrowth, aneurysm, endocarditis.Treatment included medication, balloon intervention or explant.Based on the available information a medtronic product may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

• Brand Name: CONTEGRA PULMONARY VALVED CONDUIT - SUPPORTED
• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11066996
• MDR Text Key: 223458272
• Report Number: 2025587-2020-03935
• Device Sequence Number: 1
• Product Code: MWH
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 12/23/2020

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: 200S
• Device Catalogue Number: 200S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/23/2020
• 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
• Patient Age: 9 YR
• Patient Weight: 23