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

Model Number T510

Device Problems Migration or Expulsion of Device (1395); Perivalvular Leak (1457); Material Separation (1562); Material Split, Cut or Torn (4008)

Patient Problems Host-Tissue Reaction (1297); Intimal Dissection (1333); Atrial Fibrillation (1729); Congestive Heart Failure (1783); Mitral Regurgitation (1964)

Event Date 02/01/2019

Event Type  Injury  

Manufacturer Narrative

Citation: wu w.Chronic left atrial dissection with paravalvular leakage and bioprosthetic mitral valve dysfunction at 12-year follow-up.Circ cardiovasc imaging.2019 feb;12(2): e008747.Doi: 10.1161/circimaging.118.008747.Earliest date of publish used for event date.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 a (b)(6) year-old female patient with a history of rheumatic mitral stenosis and regurgitation with left atrial thrombus who underwent left atrial thrombectomy and implant of a 27-mm medtronic hancock ii porcine bioprosthetic valve (no serial numbers provided) in the mitral position.One week post-implant echocardiography revealed mild paravalvular leakage and a left atrial sac suspected to be a dissection.Regular follow-ups over the next several years showed worsening paravalvular leakage and increasing sac size in the left atrium.As of 12 years post-implant, a transesophageal echocardiogram (tee) revealed moderate mitral regurgitation.The patient developed heart failure symptoms and also developed atrial fibrillation and was hospitalized.Transthoracic echocardiogram (tte) revealed bioprosthetic mitral valve prolapse, severe regurgitation, severe paravalvular leak and communication between the left atrium and left ventricle via a mitral periprosthetic defect with a dehiscence of the left atrial wall at the anterolateral commissure.The patient underwent surgery for mitral valve replacement with a mechanical valve, tricuspid valvuloplasty and left atrial wall repair.It was noted the bioprosthetic mitral valve had partial leaflet damage, prolapse and pannus formation.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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8713892
• MDR Text Key: 148476632
• Report Number: 2025587-2019-01987
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• 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
• Date Manufacturer Received: 05/28/2019
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 65 YR