MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT IIS BIFURCATED STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number ESBF3614C103EE

Device Problems Leak/Splash (1354); Folded (2630)

Patient Problem Injury (2348)

Event Date 04/11/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A heli-fx applier and endoanchors were used in the endovascular treatment of the patient for a type ia endoleak.The patient had an endurant stent graft system implanted on the same date.It was reported that during the index procedure, after observation of a type ia endoleak, the physician tried to operate the heli-fx applier but it malfunctioned and would only work intermittently for loading from the cassette and deployment of the endoanchor into the stent graft.The physician managed to load and implant 3 endoanchors but the remaining time the heli-fx applier wouldn't retract and the endoanchors couldn't be loaded from the cassette.It was noted that as the endoanchor could not be released fully from the heli-fx applier after deployment, the stent graft was pulled back during removal of the applier, leading to infolding of the stent graft.It is unknown whether the difficulty removing the applier after endoanchor deployment was noted before malfunctioning of the device.It was reported that only gentle force was used to pull back the stuck heli-fx applier.As per the physician, the cause of the event is due to malfunction of the applier and the cause of the type ia endoleak was due to complex anatomy of the proximal neck.The type ia endoleak was unresolved.No additional clinical sequelae were reported and the patient will be monitored.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT IIS BIFURCATED STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 7493983
• MDR Text Key: 107579351
• Report Number: 2953200-2018-00658
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: ESBF3614C103EE
• Device Catalogue Number: ESBF3614C103EE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2018
• Initial Date FDA Received: 05/08/2018
• Supplement Dates Manufacturer Received: 11/19/2018
• Supplement Dates FDA Received: 11/21/2018
• Date Device Manufactured: 01/31/2018
• 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): Required Intervention
• Patient Age: 86 YR
• Patient Weight: 88