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 Problems Regurgitation, Valvular (2335); Valvular Stenosis (2697)

Event Date 05/07/2018

Event Type  Injury  

Manufacturer Narrative

Citation: salaun e et al.Bioprosthetic aortic valve durability in the era of transcatheter aortic valve implantation.Heart.2018 a ug;104(16):1323-1332.Doi: 10.1136/heartjnl-2017-311582.Epub 2018 may 7.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 the 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 review of structural valve deterioration (svd) of aortic bioprostheses with specific emphasis on transcatheter aortic valve implant (tavi).The literature also included a meta-analysis secondary review of primary data from 23 additional articles.Medtronic products referenced were the freestyle and hancock ii surgical valves and the corevalve transcatheter valve.No patient demographics or device serial numbers were provided.Among all freestyle patients adverse events included: moderate structural valve deterioration (defined as fibrocalcific remodelling, thickening and stiffening of valve leaflets and/or disruption of collagen fibres and ensuing leaflet tear or perforation), calcification, and reintervention.Based on the available information, these adverse events may have been attributed to medtronic product.Among all hancock ii patients adverse events included: severe hemodynamic valve deterioration (defined as stenosis and/or regurgitation) and reintervention.Based on the available information, these adverse events may have been attributed to medtronic product.Among all corevalve patients adverse events included: severe structural valve deterioration (defined as fibrocalcific remodelling, thickening and stiffening of valve leaflets and/or disruption of collagen fibres and ensuing leaflet tear or perforation), structural valve failure, moderate hemodynamic valve deterioration (defined as stenosis and/or regurgitation), and reintervention including valve-in-valve procedure.Based on the available information, these adverse events may have been attributed to medtronic product.No additional adverse patient effects or product performance issues 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: 7830552
• MDR Text Key: 118706730
• Report Number: 2025587-2018-02281
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 08/29/2018

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: T505
• Device Catalogue Number: T505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 08/29/2018
• 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