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

Model Number MDT-TISSUE VALVE

Device Problem Degraded (1153)

Patient Problems Pulmonary Valve Stenosis (2024); Obstruction/Occlusion (2422); Heart Failure/Congestive Heart Failure (4446); Pulmonary Valve Insufficiency/ Regurgitation (4452); Unspecified Heart Problem (4454)

Event Date 05/04/2019

Event Type  Injury  

Manufacturer Narrative

Citation: baird cw et al.Reintervention rates after bioprosthetic pulmonary valve replacement in patients younger than 30 years of age: a multicenter analysis.J thorac cardiovasc surg.2020 sep 10;s0022-5223(20)32564-2.Doi: 10.1016/j.Jtcvs.2020.06.157.Read at the 99th annual meeting of the american association for thoracic surgery, toronto, ontario, canada, may 4-7, 2019.Earliest date of presentation used for date of event.Medtronic products referenced: hancock ii (pma# p980043, pro code dye), mosaic (pma# p990064, pro code dye), freestyle (pma# p970031, pro code lwr).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 from a literature article regarding the difference in time to and predictors of reintervention according to valve type after bioprosthetic pulmonary valve replacement in patients younger than 30 years of age.All data were retrospectively collected from eight centers between february 1996 and october 2016.The overall study population included 1,278 patients and was predominantly female.Of those, 47 patients were implanted with medtronic devices in the pulmonary position: hancock valved conduits or hancock ii bioprosthetic valves (32), mosaic bioprosthetic valves (5), freestyle bioprosthetic valves (3), and melody transcatheter pulmonary valves (7).No serial numbers were provided.Three patients treated with hancock conduits or hancock ii valves died during follow-up (mean duration of 6 years).The causes of the deaths were not characterized.Among all patients in the ¿other¿ valve type subgroup (mosaic, freestyle, melody, and non-medtronic porcine bioprosthetic valve), one death occurred at approximately 12 years and 9 months post-implant.The type of valve implanted in this patient was not disclosed.Based on the available information, medtronic product was not directly associated with these four deaths.Among all patients in the hancock and ¿other¿ valve type subgroups, adverse events included: mild to moderate pulmonary regurgitation, pulmonary stenosis, right ventricular dysfunction, and left ventricular dysfunction.Reasons for reintervention: pulmonary regurgitation (no hancock cases), pulmonary stenosis/right ventricular outflow tract obstruction, or structural valve dysfunction/deterioration.Reinterventions performed: surgical pulmonary valve replacement, transcatheter valve-in-valve replacement, or balloon dilation.The time from valve implant to reintervention ranged from approximately 7 to 14 years.Based on the available information, medtronic product was 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: 11167864
• MDR Text Key: 227031750
• Report Number: 2025587-2021-00167
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/13/2021

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: MDT-TISSUE VALVE
• Device Catalogue Number: MDT-TISSUE VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 01/13/2021
• 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