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

Model Number ETLW1616C124E

Device Problems Kinked (1339); Folded (2630)

Patient Problem Injury (2348)

Event Date 12/08/2016

Event Type  Injury  

Manufacturer Narrative

Other relevant devices are: etlw1620c124e ; (b)(4); (b)(6) 2017; (b)(4).Esbf2814c103e ; (b)(4) ; (b)(6) 2017; (b)(4).

Event Description

An endurant iis stent graft system was implanted for the endovascular treatment of an unknown abdominal aortic disease.It was reported that during a follow up, the patient was told his graft had collapsed.The implanted device was treated with angioplasty and the patient states this remedied the issue.No additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Additional information received reported that it was noted by the physician that there was a "kink" and pta was done in radiology.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Film evaluation summary; the cause of the reported mild compression of the gate could not be determined from the films provided.Films from 2016, when the event was initially reported and kissing angioplasty was completed to resolve the event, were not available for review.Review of pre-implant ct¿s revealed that the patient had a long and angulated proximal neck that ranged in diameter from 25 ¿ 21 - 22mm, with areas of calcification seen especially at the bottom of the proximal neck.The infrarenal neck was mildly angulated in the lt-rt axis to 30 deg, but was severely angulated ~80deg a-p.Ct¿s from 2 years post-implant, after the angioplasty was performed, were returned.The films were non-contrast; therefore, the measurements were approximate, and no assessment of any endoleak or stent graft/vessel patency could be performed.The bifurcate was positioned just below the renal arteries within the angulated neck; the proximal od measured ~21mm.The stent graft diameter at the bottom of the neck, near the level of the bifurcate flow divider measured ~24mm across, and a large ring of calcification was seen along the anterior of the neck.However, only minor stent graft compression (9 ¿ 10mm id) was observed with each limb just below the flow divider.Other than the minor compression seen within the distal neck, no other limb kinks, compression, or any other issues were observed.However, non-contrast films did not allow assessment of any potential stent graft thrombus/occlusion.From the films provided it appears likely that implanting within the long, angulated, and calcified proximal neck contributed to the reported stent graft compression near the gate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II ILIAC 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, CA ; 7075917650
• MDR Report Key: 7198684
• MDR Text Key: 97473235
• Report Number: 2953200-2018-00098
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169467675
• UDI-Public: 00643169467675
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2018

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: 01/28/2017
• Device Model Number: ETLW1616C124E
• Device Catalogue Number: ETLW1616C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/22/2017
• Initial Date FDA Received: 01/17/2018
• Supplement Dates Manufacturer Received: 01/30/2018; 03/01/2018
• Supplement Dates FDA Received: 02/22/2018; 03/07/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/29/2015
• 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: 66 YR
• Patient Weight: 102