MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MELODY TRANSCATHETER PULMONARY VALVE; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number PB 10

Device Problem Malposition of Device (2616)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Endocarditis (1834); Thrombosis (2100); Obstruction/Occlusion (2422); Blood Loss (2597)

Event Date 06/27/2020

Event Type  Injury  

Manufacturer Narrative

Citation: bleiziffer s et al.Long-term outcomes after transcatheter aortic valve implantation in failed bioprosthetic valves.Eur heart j.2020 jun 27;ehaa544.Doi: 10.1093/eurheartj/ehaa544.Earliest date of publish used for date of event in b3.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.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from a literature article regarding a comprehensive assessment of long-term survival and reintervention outcomes after transcatheter aortic valve-in-valve (viv) implantation.All data were retrospectively collected from the multi-center vivid (valve in valve international data) registry between april 2007 and december 2014.The study population included 1,006 patients and was predominantly male with a mean age of 78 years and a mean weight of 75 kg.Of those, 525 underwent transcatheter aortic viv implantation with medtronic transcatheter valves: corevalve or evolut r (523), and melody (2).No serial numbers were provided.Among all patients, 10 intra-procedural deaths occurred.Of those, 0.8% were treated with corevalve or evolut r.No further details were provided.Based on the available information, medtronic product was not directly associated with the deaths.Among all patients, adverse events included: second transcatheter valve implanted during the index viv procedure; permanent pacemaker implantation; valve malposition; major stroke; coronary obstruction; mild to severe aortic regurgitation (observed with corevalve and evolut r); mild to moderate aortic regurgitation (observed with melody); major vascular complications (observed with corevalve and evolut r); major bleeding; and post-procedural mean gradient greater than or equal to 20 mmhg.Types of reintervention performed over the long-term follow-up: redo transcatheter aortic valve replacement; surgical aortic valve replacement; and balloon aortic valvuloplasty.The causes of reintervention included: stenosis; regurgitation; mixed stenosis/regurgitation; endocarditis; valve thrombosis; and unknown.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: MELODY TRANSCATHETER PULMONARY VALVE
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10339822
• MDR Text Key: 203314322
• Report Number: 2025587-2020-02375
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P140017
• 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: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PB 10
• Device Catalogue Number: PB 10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2020
• 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: 78 YR
• Patient Weight: 75