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

Model Number 270027MM

Device Problems Perivalvular Leak (1457); Material Split, Cut or Torn (4008)

Patient Problems Dyspnea (1816); Fatigue (1849)

Event Date 01/23/2024

Event Type  Injury  

Manufacturer Narrative

H10: additional manufacturer narrative: the investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.

Event Description

Through implant patient registry it was learned that a 27mm 2700 valve in the aortic position, was explanted after an implant duration of 4 years, 9 months due to perforated leaflet with severe insufficiency and severe paravalvular leak.The patient presented with dyspnea and fatigue.The explanted valve was replaced with a 29mm 11500a valve.Per medical records, preoperative tee showed perforated leaflets.Operative finding includes a hole in the non-commissure cusp of the valve adjacent to the tip of the two corknots pointing towards the valve.The patient underwent redo-avr with a 29mm inspiris valve.Post procedure tee showed a well seated valve with no perivalvular leak.The patient was then transferred to the icu in stable condition.

Event Description

Through implant patient registry it was learned that a 27mm 2700 valve in the aortic position, was explanted after an implant duration of 4 years, 9 months due to perforated leaflet with severe insufficiency and severe paravalvular leak.Product investigation identified suture-tail abrasion.The patient presented with dyspnea and fatigue.The explanted valve was replaced with a 29mm 11500a valve.Per medical records, preoperative tee showed perforated leaflets.Operative finding includes a hole in the non-commissure cusp of the valve adjacent to the tip of the two cor-knots pointing towards the valve.The patient underwent redo-avr with a 29mm inspiris valve.Post procedure tee showed a well seated valve with no perivalvular leak.The patient was then transferred to the icu in stable condition.Per product evaluation, report of insufficiency was confirmed due to perforated leaflet.Report of paravalvular leak was unable to be confirmed through visual observation.Perforation was observed on leaflet 3.The perforation was beveled at the outflow aspect, a typical characteristic of those caused by suture tail/fastener abrasion.No sutures or fasteners remained on the sewing ring around leaflet 3, however suture holes were visible.Moderate host tissue overgrowth encroached onto the tissue and into the host tissue fused leaflets 1 and 3 by approximately 1mm at commissure 1.

Manufacturer Narrative

The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.H3: customer report of perforated leaflet was confirmed.Report of insufficiency was confirmed due to perforated leaflet.Report of paravalvular leak was unable to be confirmed through visual observation.The x-ray demonstrated wireform intact.A 5mm x 6mm perforation was observed on leaflet 3.The perforation was beveled at the outflow aspect, a typical characteristic of those caused by suture tail/fastener abrasion.No sutures or fasteners remained on the sewing ring around leaflet 3, however suture holes were visible.Moderate host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 7mm on leaflet 1 on the inflow aspect.Minimal host tissue overgrowth encroached onto the tissue and into the orifice at the greatest distance of approximately 1mm on leaflet 1 at the outflow aspect.Host tissue on the stent circumference was minimal at both the inflow and outflow aspects.Host tissue fused leaflets 1 and 3 by approximately 1mm at commissure 1.Wireform was exposed on commissure 2.A suture pledget remained attached to the host tissue near commissure 1 on the inflow aspect.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.

Manufacturer Narrative

H11: additional manufacturer narrative: updated: b4, g3, g6, h2, h6 based on the provided information, the most likely of cause the leaflet damage is procedural factors, including suture tail abrasion which is considered use-related as it is caused by the surgeon's suture placement and leaving the tails at a length and position where they contact the leaflet.An edwards defect has not been confirmed.Regurgitation is considered to be a perivalvular leak (pvl) if a turbulent eccentric jet originates between the bioprosthetic sewing ring and the annulus.Pvl can occur in the mitral and aortic position for similar reasons.In the early postoperative period, the highest incidence of pvl has been seen in patients developing infective endocarditis, which is most likely attributed to inadequate peri-operative antibiotic prophylaxis or nosocomial infection.Annular calcification is also a risk factor for the development of peri-operative pvl as the bioprosthesis may not seat properly after debridement.Technique related factors, such as incorrect valve sizing, have been shown to contribute to the development of pvl.Anatomical factors may create difficulty seating the bioprosthetic valve resulting in pvl.The anatomy of the annulus may induce mechanical stresses along the rigid bioprosthetic ring which can influence long-term valve performance and durability.A diseased or rigid annulus can potentially increase the mechanical stress on the prosthetic valve, leading to pvl.The instructions for use (ifu) have been reviewed and no inadequacies have been identified with regard to warnings, contraindications, and the directions/conditions for the successful use of the device.The reported type of event is included in the ifu.A definitive root cause of the pvl cannot be conclusively determined; however, patient and/or procedural factors likely caused or contributed.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 18769232
• MDR Text Key: 336126635
• Report Number: 2015691-2024-01279
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2021
• Device Model Number: 270027MM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male