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

Model Number T505C221

Device Problems Material Puncture/Hole (1504); Material Perforation (2205); Dent in Material (2526); Biocompatibility (2886); Naturally Worn (2988)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717)

Event Date 10/10/2019

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 19 months post implant of this 21mm aortic bioprosthetic valve, it was explanted and replaced due to severe aortic stenosis.Upon explant it was noted that there were two holes in the valve leaflet which were reported to not be due to infection or endocarditis.No additional adverse patient effects were reported. .

Manufacturer Narrative

Conclusion:the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.A likely cause of the regurgitation may be from contact with the bias cloth and the long suture tail, however, with the available information, a conclusive root cause cannot be determined at this time.The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 19 months post implant of this 21mm aortic bioprosthetic valve, it was explanted and replaced due to severe aortic regurgitation.Upon explant it was noted that there were two holes in the valve leaflet which were reported to not be due to infection or endocarditis.No additional adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, long blue and white multifilament suture trails remained attached to the sewing ring adjacent to the non-coronary cusp, right non-coronary and left non-coronary stent posts.Most of the sewing ring appeared to have been removed during explant exposing part of the stent.The right-coronary and non-coronary cusps were in the closed position while left cusp was partially open.All leaflets were slightly stiff but flexible except where host tissue extended on the inflow of all cusps.A perforation in the lunula of the left cusp appeared to be due to contact with the bias cloth along the inner outflow rail.A perforation in the lunula of the right cusp appears to be due to either contact with the bias cloth along the inner outflow rail or a potential long suture tail.An indentation on inner outflow rail appeared to have been the location of a long suture.All commissures were intact.Traces of pannus are observed along the sewing ring and along the right, left and non-coronary outflow rails.Pannus lined the inflow margin of attachment between non-coronary and left cusps.An unknown amount of pannus appeared to have been removed during explant.Conclusion: the investigation is in progress.Upon completion of the investigation, a supplemental report will be submitted.B5: corrected the event description.H6: corrected patient code h6: updated device, result, and conclusion codes 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 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
• MDR Report Key: 9271266
• MDR Text Key: 164810498
• Report Number: 2025587-2019-03366
• 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,Followup
• Report Date: 04/06/2020

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: 06/04/2022
• Device Model Number: T505C221
• Device Catalogue Number: T505C221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Initial Date Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 11/04/2019
• Supplement Dates Manufacturer Received: 01/29/2020; 03/13/2020
• Supplement Dates FDA Received: 02/28/2020; 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 64