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

Model Number T510C29

Device Problems Material Puncture/Hole (1504); Material Separation (1562); Incomplete Coaptation (2507); Material Deformation (2976); Patient Device Interaction Problem (4001)

Patient Problems Corneal Pannus (1447); Mitral Regurgitation (1964); Thrombus (2101); Cusp Tear (2656)

Event Date 12/12/2018

Event Type  Injury  

Manufacturer Narrative

The product has been returned and analysis is in progress.Upon completion of analysis, a supplemental report will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that five years and nine months post implant of this 29mm mitral bioprosthetic valve, the valve was explanted and replaced with a non-medtronic mechanical valve due to severe insufficiency.During the procedure prior to removal of the bioprosthetic valve, one leaflet was noted to be ruptured, and a second leaflet was noted to be retracted and fibrosed.The third leaflet had normal appearance.The majority of the valve was extracted, while the subvalvular "apparatus" that was preserved in the previous surgery was retained, due to it being partially attached to the frame of the bioprosthetic valve.No additional adverse patient effects were reported. .

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, visual examination revealed that the sewing ring was damaged, which likely occurred during the explant procedure.Remnants of chordae tendineae were attached to the right non-coronary and left right stent posts and rail on the outflow.The valve appeared slightly distorted.All leaflets were in the closed position with the tear on the left cusp (lc) impeding a closure.All leaflets were slightly stiff but flexible except where host tissue had extended on the inflow and outflow.The non-coronary cusp (nc) was immobile as result of the host tissue overgrowth on the outflow.A large tear, approximately 7mm, from the free margin to the belly of the left cusp (lc) and a smaller tear, approximately 4 mm, on the free margin of the left cusp (lc) were observed and appeared to have originated from the restricted leaflet movement due to host tissue overg rowth on the left non-coronary commissure.There were tears in the left (lc) and right (rc) cusps, associated with restricted leaflet movement due to host tissue overgrowth on the left right commissure.All commissures and stent posts were encapsulated with pannu s extending to the their superior coaptive areas; therefore, the condition of the commissures could not be assessed.Remnants of glistening off-white pannus lined the inflow sewing ring and base stitching encroaching to the inferior coaptive areas of all cusps.Thick glistening off-white pannus was observed on the outflow sewing ring extending to the outflow rails and backs of all stent posts.Pannus overgrowth lined the outflow margin of attachment of all cusps.An unknown amount of pannus appeared to have been removed during explant.Radiologic evaluation revealed focal calcification on the left right commissure.Conclusion: investigation is ongoing, a supplemental report will be submitted should any new or additional information become available.Reduced performance of the valve is attributed to host tissue overgrowth.This finding is generally considered a patient-related condition.Added: manufactured date, product id, serial number and use before date.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HANCOCK II MITRAL 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
• MDR Report Key: 8270795
• MDR Text Key: 133859731
• Report Number: 2025587-2019-00278
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P980043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/02/2019

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 Expiration Date: 02/16/2017
• Device Model Number: T510C29
• Device Catalogue Number: T510C29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Initial Date Manufacturer Received: 12/28/2018
• Initial Date FDA Received: 01/23/2019
• Supplement Dates Manufacturer Received: 05/01/2019
• Supplement Dates FDA Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 72