MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HANCOCK II MITRAL BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number T510

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Non specific EKG/ECG Changes (1817); Myocardial Infarction (1969); Rupture (2208); Heart Block (4444)

Event Date 04/01/2021

Event Type  Injury  

Manufacturer Narrative

Citation: kadan m, et al.Early- and mid-term results of cryoablation of atrial fibrillation concomitant with robotic mitral valve surgery.Anatol j cardiol.2021 apr;25(4):266-272.Doi: 10.14744/anatoljcardiol.2020.81669.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 early and mid-term results of cryoablation for atrial fibrillation (afib) concomitant with robotic mitral valve surgery.All data were retrospectively collected from a single center between 2014 and 2020.The study population included 34 patients (predominantly female, mean age 58 years), all of whom were implanted with either a medtronic open pivot mechanical heart valve, hancock bioprosthetic valve, profile 3d or contour 3d annuloplasty ring.Serial numbers were not provided.Among all patients, two deaths occurred due to low cardiac output syndrome and hepatorenal syndrome and were not attributed to a medtronic device among all patients, adverse events included: first degree heart block, new onset atrial fibrillation (afib) and complete heart block (chb) treated with permanent pacemaker, left ventricle rupture treated with a sternotomy and myocardial ischemia treated with the implant of a stent.Based on the available information, a medtronic product may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

• Brand Name: HANCOCK II MITRAL BIOPROSTHETIC HEART 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: 11973920
• MDR Text Key: 255343396
• Report Number: 2025587-2021-01839
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P980043
• 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: 06/10/2021

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: T510
• Device Catalogue Number: T510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2021
• Initial Date FDA Received: 06/10/2021
• 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): Required Intervention
• Patient Age: 58 YR