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

Model Number 200S

Device Problem Calcified (1077)

Patient Problem Insufficient Information (4580)

Event Date 05/15/2019

Event Type  Injury  

Manufacturer Narrative

Citation: lueck s et al.Hydroxylapatite deposition induces graft alterations in chd patients.Cardiology in the young.2019; 29(supp.1):s84.Doi: 10.1017/s1047951119000489, 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 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 a retrospective analysis into the calcification-dependent alterations of various types of grafts in patients with congenital heart disease.All data were collected from a single center.The study population included 7 patients, 3 of whom were implanted with medtronic contegra pulmonary valved conduit (unique device identifier numbers not provided).Among all medtronic contegra patients, adverse events included: conduit explantation due to calcium-based deposits (calcium phosphates and hydroxylapatite).Based on the available information medtronic product was directly 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: PULMONIC VALVED CONDUIT
• 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: 12443406
• MDR Text Key: 270488126
• Report Number: 2025587-2021-02764
• Device Sequence Number: 1
• Product Code: MWH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: H020003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2021

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: 08/24/2021
• Initial Date FDA Received: 09/08/2021
• 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): Hospitalization; Required Intervention