MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS; REPLACEMENT HEART-VALVE

Model Number	3000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Bioprosthetic tissue valves can deteriorate with time and eventually fail contributing to regurgitation and/or stenosis.Structural valve deterioration (svd) is the most common reason for bioprosthesis explants and encompasses multiple failure modes, including calcification, non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.Alternatively, nonstructural dysfunction (nsvd) may also play a role in the development of valvular regurgitation and/or stenosis.Multiple requests for additional details regarding this event (i.E., medical records) have been performed; however, no additional information has been provided.The subject device is also unavailable for evaluation as it remains implanted in the patient.Therefore, the reported event could not be confirmed.There is currently insufficient information to determine the root cause of this event.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.If any additional information is received, a supplemental report will be submitted accordingly.
Event or Problem Description
Through edwards implant patient registry, it was reported that a patient with a 21mm 3000 pericardial valve, implanted in the aortic position, underwent a valve-in-valve procedure after an implant duration of 12 years, four (4) months due to unknown reasons.The tavr was performed with a 23mm 9750tfx transcatheter valve.No additional information has been provided.Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional "customer complaint".The information reported may or may not be related to the edwards device.
Event or Problem Description
Through edwards implant patient registry, it was reported that a patient with a 21mm 3000 pericardial valve, implanted in the aortic position, underwent a valve-in-valve procedure after an implant duration of 12 years, four (4) months due to unknown reasons.The tavr was performed with a 23mm 9750tfx transcatheter valve.There was no investigational evidence of a premature failure.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: the device history record (dhr) review was completed, and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.Updated b5, d4, h4, h6 h11: corrected data: based on the additional information obtained, this event is no longer considered reportable, and this correction is being submitted.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 12455164
• Report Number: 2015691-2021-05117
• Device Sequence Number: 14469953
• Product Code: DYE
• UDI-Device Identifier: 00690103162240
• UDI-Public: 00690103162240
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

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: 01/05/2013
• Device Model Number: 3000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 81 YR