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

Model Number 3300TFX

Device Problems Calcified (1077); Degraded (1153); Gradient Increase (1270); Appropriate Term/Code Not Available (3191)

Patient Problems Abscess (1690); Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758); Endocarditis (1834); Mitral Valve Stenosis (1965); Organ Dehiscence (2502)

Event Date 06/19/2020

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: bioprosthetic tissue valves can deteriorate with time and eventually fail contributing to 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.In this case, calcification was indicated.Calcification plays a major role in the failure of bioprosthetic heart valves.Calcification of valves occurs as a progressive, time-dependent process.Tissue valve calcification is initiated primarily within residual cells that have been devitalized.Initial calcification deposits eventually enlarge and grow into a mass, which stiffen and weaken the tissue and thereby cause the prosthesis to malfunction.The mineralization of a biomaterial is generally enhanced at the sites of intense mechanical deformations generated by motion, such as the points of flexion in heart valves.Ultimately, the result of calcification is valve failure due to tearing or stenosis.Many factors contribute to the onset and propagation of calcification.These include patient factors (age, disease state, pharmacological intervention, etc.), mechanical stress related to the valve's hemodynamic performance, and glutaraldehyde fixation of tissue.Of these, the fixation process is a relatively minor contributor to calcification for edwards' tissue valves due to anti-calcification treatments during manufacturing.Though numerous studies have been conducted on preventive calcification strategies in bioprosthetic heart valves, the causes of calcification are not fully understood and there are still no mechanisms or medical therapies which fully prevent bioprosthesis from calcifying.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.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.

Event Description

It was reported through implant patient registry that a 25mm 3300tfx aortic valve was explanted after an implant duration of four (4) years, six (6) months due to endocarditis, root abscess, valve dehiscence, severely calcified and degenerated valve leading to severe aortic stenosis.Per the medical records, intraoperative findings showed peri-annular abscess with large amounts of purulent material.Severe aortic valve infection with dehiscence of the aortic bioprosthetic valve was found.The valve and previous dacron material were removed and in the process abscess was identified under the left coronary button and non-coronary sinus extending into the septum.Due to risk of infection, the surgeon elected to place a 23mm aortic valve homograft.Aortic root replacement with a 23mm homograft was also performed, ppm placed.Tee showed good function of the homograft aortic valve.The patient was transferred to the cticu in critical condition on va ecmo support.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 reported through implant patient registry that a 25mm 3300tfx aortic valve was explanted after an implant duration of four (4) years, six (6) months due to endocarditis (cryptococcus/ staphylococcus epidermidis), root abscess, valve dehiscence, severely calcified and degenerated valve leading to severe aortic stenosis.Per the medical records, the patient presented with staph epidermidis bacteremia, chb, and concern for endocarditis -source thought to be hd access. on hospital day #7, he was taken to the or for explant of the 3000tfx.Intraoperative findings showed peri-annular abscess with large amounts of purulent material.Severe aortic bioprosthetic valve infection with dehiscence was found.Due to risk of infection, the surgeon elected to place a 23mm aortic valve homograft.Aortic root replacement with a 23mm homograft was also performed, ppm placed.Tee showed good function of the homograft aortic valve.The patient was discharged home pod #25.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

H10: additional manufacturer narrative: updated sections: a4, b5 and b7.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
• Type of Device: HEART-VALVE, REPLACEMENT
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10289566
• MDR Text Key: 199685280
• Report Number: 2015691-2020-12549
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• PMA/PMN Number: P860057/S42
• 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: 06/22/2020

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: 08/20/2019
• Device Model Number: 3300TFX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 36 YR
• Patient Weight: 84