MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INSPIRIS RESILIA AORTIC VALVE; TISSUE, HEART-VALVE

Model Number 11500A

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 11/19/2020

Event Type  Injury  

Manufacturer Narrative

Cloth tears or snags typically result from penetration by needle/suture during implant or less commonly non-conformances in the valve assembly process.If a cloth tear or snag resulting in a loose fragment is not detected by the operating team, and the device is implanted, there may be fibers of the cloth exposed to the bloodstream.In a worst-case scenario, a fiber could separate and embolize distally.If the fragment was large enough, it could theoretically serve as a nidus for thrombus in the microcirculation and cause permanent damage to a small amount of tissue.The device is in the process of being returned for evaluation.If new information becomes available, a supplemental report will be submitted.

Event Description

Edwards received information that a fiber came out from the cuff of this 23mm aortic valve during use.The fiber came out at the same time as putting the needle through the sewing ring.The doctor commented that it was unknown whether this event was device related.

Manufacturer Narrative

Updated d4 and h4 per new information received.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.

Manufacturer Narrative

H10: additional manufacturer narrative.Updated h3 per new information received.H3: product evaluation.Customer report of loose thread was confirmed.A piece of white thread approximately 3.5 cm long was returned.Valve was not returned.One end of the thread appeared cut with straight and even edges at the cloth bundles.The other end of the thread appeared torn with uneven and frayed ends.Per ft-ir report the sample spectrum is consistent with that of ptfe.H11: corrected data.Based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: TISSUE, HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10992307
• MDR Text Key: 220972197
• Report Number: 2015691-2020-14968
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2021
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/11/2020
• Supplement Dates Manufacturer Received: 12/19/2020; 01/19/2021
• Supplement Dates FDA Received: 01/15/2021; 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention