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

Model Number 242

Device Problems Perivalvular Leak (1457); Material Deformation (2976)

Patient Problems Corneal Pannus (1447); Calcium Deposits/Calcification (1758); Endocarditis (1834); Hematoma (1884); Thrombus (2101); Cusp Tear (2656); Valvular Stenosis (2697)

Event Date 01/01/1990

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.The serial numbers are unknown, therefore no manufacturing or expiration dates are possible and no the device history record is possible.The gender is most prominent and the age is average age.The date of the event used is the year of the article publication.Citation: title: the pathology of hancock standard porcine valve prosthesis: a 20-year span of experience authors: marialuisa valente, marco minarini, gaetano thiene, uberto bortolotti , aldo milano, enrico talenti and vincenzo gallucci journal name: journal of cardiac surgery year of publication: 1990 issue number: volume 5, issue 4, pages 328¿335 literature reference: 10.1111/j.1540-8191.1990.Tb00763.(b)(4).

Event Description

Medtronic received information via literature review regarding tissue failure for late dysfunction of this bioprosthetic valve.All data were collected from a single center in 1990.The study population included 278 long-term bioprosthetic implants predominantly female; mean age 43 years).Serial numbers not provided.The average length of device implant time was 104 months.Among all patients, adverse events included: calcification, stenosis, pannus, thrombosis, cuspal hematoma( likely a complication of the patient's anticoagulation therapy), cuspal tears causing paravalvular leak, endocarditis (of a aspergillus species infiltrating the cusp tissue) and valve post-bending due to degeneration.In conclusion of the article it states that dystrophic calcification is the major threat to this bioprosthetic valve longevity and accounts for different modes of failure and clinical presentation, whereas primary tears play a negligible role.Eighty-eight percent of the failure were due to calcification leading to other factors.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: HANCOCK AORTIC BIOPROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e. deere ave.; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVE 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: 5768003
• MDR Text Key: 48711555
• Report Number: 2025587-2016-00969
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P980043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2016

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 242
• Device Catalogue Number: 242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2016
• Initial Date FDA Received: 07/04/2016
• Supplement Dates Manufacturer Received: 06/13/2016
• Supplement Dates FDA Received: 09/24/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 43 YR