MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MEDTRONIC SURGICAL TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number MDT-TISSUE VALVE

Device Problems Partial Blockage (1065); Calcified (1077); Fluid/Blood Leak (1250); Material Rupture (1546)

Patient Problems Calcium Deposits/Calcification (1758); Rupture (2208); Stenosis (2263); Obstruction/Occlusion (2422); Pulmonary Valve Insufficiency/ Regurgitation (4452)

Event Date 09/26/2014

Event Type  Injury  

Manufacturer Narrative

Citation: bishnoi r., et al.Numed covered cheatham-platinum stenttm for the treatment or prevention of right ventricular outflow tract conduit disruption during transcatheter pulmonary valve replacement.Catheter cardiovasc interv, 2015 feb 15;85(3):421-7.Doi: 10.1002/ccd.25682.Published online 26 september 2014.Earliest date of publish used for event date.Medtronic products referenced: hancock; contegra; mosaic (pma#s p790007; h020003; p990064.Product codes: lwr; mhw; dye), melody (pma# p140017.Product code: npv).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 the use of a covered wire stent to prevent right ventricular outflow tract (rvot) disruption/injury during transcatheter pulmonic valve replacement (tpvr).All data were collected retrospectively from multiple centers between september 2009 and july 2012.The study population included 50 patients, 48 of whom were implanted with medtronic melody bioprosthetic valves under tpvr (no serial numbers provided).Of this patient population, four had medtronic hancock valved conduits, two had medtronic contegra valved conduits and one had a medtronic mosaic bioprosthetic valve previously implanted in the rvot (no serial numbers provided).Among all medtronic hancock/contegra/mosaic patients, adverse events included: rvot obstruction/stenosis, conduit calcification and pulmonic regurgitation, requiring tpvr as treatment, and rvot conduit tears discovered prior to conduit dilatation/valve implantation, requiring covered stent placement in the rvot.Based on the available information, medtronic product may have been associated with the adverse events.Among all medtronic melody patients, adverse events included: rvot conduit tears/ruptures and pulmonary hemorrhage during or after balloon dilatation and tpvr, requiring covered stent placement in the rvot, conduit replacement surgery, pleurocentesis with chest tub placement to stop bleeding.Melody valve incompetence required valve-in-valve implantation with second melody valves for resolution.Multiple stent fractures occurred in one patient's valve, resulting in fragment embolization and requiring stent placement for physical support.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: MEDTRONIC SURGICAL TISSUE VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• 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: 10989748
• MDR Text Key: 220885718
• Report Number: 2025587-2020-03751
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MDT-TISSUE VALVE
• Device Catalogue Number: MDT-TISSUE VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2020
• 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): Life Threatening; Required Intervention