MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS BIOPROSTHESIS; HEART-VALVE, REPLACEMENT

Model Number 2625

Device Problems Calcified (1077); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/1998

Event Type  Injury  

Manufacturer Narrative

The device was explanted > 0 days for unknown reasons.Although there are multiple root causes, valves are typically explanted because they are not functioning optimally.Re-operative valve surgery carries significant risk.The device was not returned for evaluation, as the device status is unknown.Minimal information regarding this procedure was received and attempts to get additional information regarding the condition of the device, patient's medical history, or possible comorbidities have been unsuccessful.The root cause of the event remains indeterminable.If new information becomes available, a supplemental report will be submitted.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

It was learned via medical records that a 27mm porcine aortic valve was explanted after an unknown implant duration due to unknown reasons.An unknown model valve was implanted.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 Description

It was learned via medical records that a 27mm porcine aortic valve was explanted after an approximate implant duration of 11 years due to unknown reasons.A homograft was implanted.

Manufacturer Narrative

H10: additional manufacturer narrative.Updated b3, b5, d7, e1, and h6 per new information received.

Manufacturer Narrative

H10: additional manufacturer narrative.Updated b3, b5, b7, e1, f10, and h6 per new information received bioprosthetic valves are prone to structural valve degeneration (svd) due to a gradual, multi-year process of calcification of the leaflets resulting from the pre-existing disease process.It may present as regurgitation and/or stenosis.This is an expected and foreseeable result in valves that have been implanted long term and are near the end of its established life expectancy.The device was not returned for evaluation, as it was discarded.The root cause of this event cannot be conclusively determined.However, it is likely that the progression of the underlying valvular disease pathology contributed to the event.

Event Description

It was learned via medical records that a 27mm porcine aortic valve was explanted after an implant duration of 10 years, 11 months due to mild calcification.A homograft was implanted.Patient was discharged on pod #4.Per medical records patient presented with severe mr and underwent redo-avr + mv repair.The aortic porcine valve appeared to be functioning well.The patient did not want to be on coumadin and he requested a replacement of his porcine aortic valve with an aortic valve homograft if the surgical team could repair his mitral valve.Intra-operatively, the porcine aortic valve was well seated although there was mild calcification in the leaflets with normal appearance.Post-implant echo demonstrated well functioning mitral valve and aortic valve homograft without insufficiency.When the patient was adequately warmed he was weaned from cardiopulmonary bypass without difficulty.The patient tolerated the procedure well and was brought to the cvicu in stable condition.There is no investigational evidence suggesting the porcine aortic valve failed prematurely.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.

Manufacturer Narrative

H11: corrected data: corrected sections h6 (method & conclusions codes).Based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

• Brand Name: CARPENTIER-EDWARDS BIOPROSTHESIS
• Type of Device: HEART-VALVE, REPLACEMENT
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10292340
• MDR Text Key: 199871254
• Report Number: 2015691-2020-12579
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• PMA/PMN Number: P870056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/23/1991
• Device Model Number: 2625
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR