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

Model Number 11500A

Device Problem Material Integrity Problem (2978)

Patient Problem Laceration(s) (1946)

Event Date 02/01/2023

Event Type  Injury  

Event Description

It was reported that the "plastic stent prongs" holding a 25mm aortic valve holder broke during implant causing a small tear in the wall of the aorta which required repair.The repair was performed with a single stitch.The patient was doing well.Per rep "plastic stent prongs" refer to the legs of the valve holder.As the device was being removed, once the suture holding the valve onto its implant frame had been cut, one of the prongs was bent.Only that one of the prongs holding the valve had reportedly broken.The device remained intact structurally with no separate pieces being reported.No pieces fell into the patient.

Manufacturer Narrative

There are times when the surgeon has difficulty using or deploying the holder during the procedure.This typically results in a degree of extra effort by the surgeon but does not usually result in an inability to implant the device.It can also result in the device not being placed accurately and requires explant.The device was not returned for evaluation, as the holder was discarded.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

It was reported that the plastic stent prongs holding a 25mm aortic valve holder broke during implant causing a small tear in the wall of the aorta which required repair.The repair was performed with a single stitch.The patient was doing well.Per rep plastic stent prongs refer to the legs of the valve holder.As the device was being removed, once the suture holding the valve onto its implant frame had been cut, one of the prongs was bent.Only that one of the prongs holding the valve had reportedly broken.The device remained intact structurally with no separate pieces being reported.No pieces fell into the patient.Per medical records the patient presented with moderate as and mild ai and underwent cabg x 3 and avr.There was a break in the plastic prong on the valve holder when it was lowered in the annulus, causing a tear of the oblique aortotomy, which was easily repaired.The patient was discharged home on pod #4.

Manufacturer Narrative

H10: additional narratives : updated b5 and h6 per new information received.

Manufacturer Narrative

H10: additional narratives: updated b5 per new information received.

Event Description

It was reported that the plastic stent prongs holding an 11500a 25mm aortic valve holder broke during implant causing a small tear in the wall of the aorta which required repair.The repair was performed with a single stitch.The patient was doing well.Per rep plastic stent prongs refer to the legs of the valve holder.As the device was being removed, once the suture holding the valve onto its implant frame had been cut, one of the prongs was bent.Only that one of the prongs holding the valve had reportedly broken.The device remained intact structurally with no separate pieces being reported.No pieces fell into the patient.Additional info provided by the surgeon: the plastic mechanism that was reported came about as a result of the surgeon rocking the valve back and forth to seat it properly inside of a very tight stj.The conduit the surgeon was working in was quite narrow and the surgeon was having to maneuver the valve aggressively to get it into its position at the annulus.That was when the holder broke.The surgeon mentioned that the valve seated as it should and was sewn in with no issues.Per medical records the patient presented with moderate as and mild ai and underwent cabg x 3 and avr.There was a break in the plastic prong on the valve holder when it was lowered in the annulus, causing a tear of the oblique aortotomy, which was easily repaired.The patient was discharged home on pod #4.

Manufacturer Narrative

H10: additional narratives updated h6 per new information received the most likely root cause of the event is procedural factors, including customer handling during device implantation.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; one edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 16444800
• MDR Text Key: 310268909
• Report Number: 2015691-2023-11117
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00690103194999
• UDI-Public: (01)00690103194999(17)260223(11)220224218938509
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11500A
• Device Catalogue Number: 11500A25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male