MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MEDTRONIC SURGICAL MECHANICAL VALVE; HEART-VALVE, MECHANICAL

Model Number MDT-MECH VALVE

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Transient Ischemic Attack (2109); Thrombosis/Thrombus (4440)

Event Date 09/09/2014

Event Type  Injury  

Manufacturer Narrative

Citation: koertke et al.Telemedicine-guided, very low-dose international normalized ratio self-control in patients with mechanical heart valve implants.Eur heart j.2015 jun 1;36(21):1297-305.Doi: 10.1093/eurheartj/ehu330.Epub 2014 sep 9.Earliest date of publish used for date of event.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 low-dose international normalized ratio self-control in patients with mechanical heart valve implants.All data were collected from multiple centers from january 2006 to april 2012.The study population included 1,571 patients who were predominantly male with an approximate mean age of 58 years.Multiple manufacturer¿s devices were implanted in the study population; eight patients were implanted with medtronic mechanical prosthetic heart valves (model and/or unique device identifier numbers were not provided).Among all patients, 29 deaths occurred due to: myocardial infarction, sepsis, tumor, sudden cardiac death, aortic aneurysm, surgery-related bleeding, cardiac failure, kidney failure, sepsis, and multiple organ failure.Based on the available information medtronic product was not directly associated with the death(s).Among all patients, adverse events included: major bleeding complications, and thrombotic events resulting in stroke, transient ischemic attack (tia), or ischemia.Another outcome of stenosis was stated as being unrelated to a valve.Based on the available information medtronic product may have been associated with the adverse event(s).No additional adverse patient effects or product performance issues were reported.

• Brand Name: MEDTRONIC SURGICAL MECHANICAL VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• 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: 12350457
• MDR Text Key: 267619516
• Report Number: 2025587-2021-02613
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P990046
• 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: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: MDT-MECH VALVE
• Device Catalogue Number: MDT-MECH VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2021
• 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): Life Threatening
• Patient Age: 58 YR