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

Model Number T505

Device Problem Insufficient Information (3190)

Patient Problem Thrombus (2101)

Event Date 04/01/2007

Event Type  Injury  

Manufacturer Narrative

Citation: riess fc et al.Hemodynamic performance of the medtronic mosaic porcine bioprosthesis up to ten years.Ann thorac surg.2007 apr;83(4):1310-8.Doi: 10.1016/j.Athoracsur.2006.07.034.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding hemodynamic performance of the medtronic mosaic porcine bioprosthesis up to ten years.All data were collected from a single center between february 1994 and october 1999.The study population included 255 patients (predominantly male; mean age 67 years).All of them were implanted with medtronic mosaic prosthesis.In two patients, the valve was replaced with hancock ii and mechanical valve due to valve thrombosis.The serial numbers were not provided.Among all patients early mortality was reported in 2 patients ¿ one death due to hypertrophic obstructive cardiomyopathy, and another death dye to acute pericardial tamponade/aortic dissection/perforation on postoperative day 13.There was no evidence that either of the deaths were device related.The 3 valve related deaths were due to a hemorrhagic cerebral vascular accident (cva) in a patient on a long-acting oral anticoagulant drug due to atrial fibrillation (afib) 2119 days post implant, endocarditis 3098 days post implant, and heart failure 983 days after implant.Based on the available information, none of the deaths were attributed to medtronic product.Among all patients adverse events included: structural valve deterioration, prosthesis thrombosis, transient neurologic event, stroke, cerebral hematoma, subdural hematoma, thromboembolism, major hemorrhage, paravalvular leak (pvl), aortic regurgitation (ar), aortic stenosis, prosthesis mismatch, prosthetic endocarditis, valve replacement, reoperation and explant.Based on the available information, a direct correlation was likely between the observed adverse events and medtronic product.No additional adverse patient effects or product performance problems were reported.

• Brand Name: HANCOCK II AORTIC 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: 7528254
• MDR Text Key: 108720429
• Report Number: 2025587-2018-01192
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Health Professional
• Type of Report: Initial
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: T505
• Device Catalogue Number: T505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2018
• 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: 67 YR