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

Model Number	T510C31
Medical Device Problem Codes	Calcified (1077); Incomplete Coaptation (2507); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Insufficient Information (4580)
Date of Event	07/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: the product has been returned and analysis is in progress.Upon completion of analysis, a supplemental report will be submitted.Date of event is unknown.Explant date (2021 reports): explanted date is unknown.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that an unknown duration post implant of this 31mm bioprosthetic mitral valve, it was explanted and replaced with an unknown device.The reason for the replacement was not reported.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic received additional information that the valve was replaced 7 years and 6 months post implant.The reason for replacement was bi-leaflet prolapse secondary to advanced barlow's pathology and chordal rupture.No additional adverse patient effects were reported.A2: updated age at time of event a4: updated pt weight b3: updated date of event d6b: updated explant date g3: corrected date mfr received h6: codes updated.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.
Additional Manufacturer Narrative
Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed that the sewing ring was damaged likely due to explant procedure.All leaflets were received in the closed position.The left cusp was prolapsed on the inflow with the right cusp exhibiting a twisted appearance.All leaflets were slightly stiff yet pliable in areas with no visible calcification and/ or pannus.Calcification nodules noted on the inferior coaptive area between the left and right cusps appearing to contribute to the adjacent tissue deterioration on the left cusp.The left cusp was prolapsed, likely a result of the leaflet deterioration on the left right commissure.Abrasion was noted on the right cusp possibly from the interaction between the free margin of the left cusp and the belly of the right cusp creating an approximate 4mm-5mm hole.Calcification was observed on the left right commissure with a thin layer of pannus on the superior coaptive junction.Pannus noted on the right non-coronary commissure.Layer of pannus partially e ncapsulated the left non-coronary commissure with adjacent calcification nodule on the left cusp.Inflow: light tan pannus observed along the sewing ring extending base stitching and margin of attachment of all cusps.Outflow: remnants of thick off-white pannus remained attached to the sewing ring adjacent to the left and non-coronary cusps, extending to the non-coronary and left outflow rails and encapsulating the back of the left non-coronary stent post.Radiography revealed extensive calcification on the left right and left non-coronary commissural areas and to a lesser extent on the right non-coronary commissural areal and left cusp.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.The pannus and calcification found on the returned valve are known, inherent risks of bioprosthetic valve replacement and can be a patient-related condition.In addition, the reason for replacement of the bioprosthesis was bi-leaflet prolapse secondary to advanced barlow's pathology and chordal rupture, which is a patient related condition.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
• Common Device Name: 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12501953
• Report Number: 2025587-2021-02847
• Device Sequence Number: 3937675
• Product Code: DYE
• UDI-Device Identifier: 00643169027121
• UDI-Public: 00643169027121
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P980043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/23/2016
• Device Model Number: T510C31
• Device Catalogue Number: T510C31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 07/28/2021; 12/08/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 10/07/2021; 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 96 KG