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

Model Number ETLW1616C124EE

Device Problem Material Deformation (2976)

Patient Problems Unspecified Infection (1930); Necrosis (1971); No Consequences Or Impact To Patient (2199); Embolism/Embolus (4438); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An endurant ii bifurcate stent graft system was implanted in the endovascular treatment of a 58mm abdominal aortic aneurysm.It was reported that during the index procedure, the main body stent graft etbf3216c145ee was landed below the renal arteries in a slightly angulated aortic neck.When attempting to remove the top cap of the delivery system, it got caught on the left side of the supra renal stent,.Attempts to remove it with normal bail out techniques i.E rocking the system anti clockwise and clockwise, insertion of balloon to move the delivery system away from aortic wall, insertion of multiple stiff wires were unsuccessful.Finally, the delivery system was eventually removed by pressing on the patients left abdomen which allowed the delivery system to be removed.When deploying the contra lateral limb etlw1616c124ee, the grey front grip component came apart in the physicians hands, there was no extraordinary force applied or any visual defects when device was opened, the stent was then implanted with no issues.On final angiogram, an unknown endoleak was present which was considered but could not be established if it is a type 1a or type ii as the patient was noted to have some large lumbar arteries.As per the physician the cause of the events can not be determined.No additional clinical sequelae were provided and the patient will be monitored.

Manufacturer Narrative

Additional information received; the patient was readmitted post op with infected necrosis observed on the tip of the left second toe and dusky adjacent toes consistent with microemboli presumed to have occurred on day of surgery from all the manipulation, no significant occlusive disease and no other embolectomy source was observed on cta.It was reported that there were no endoleaks observed on the follow up ct and no further intervention was required.A4: updated b7: updated if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: the delivery system returned with the front grip detached from the screw gear.A kink was observed on the graft cover immediately distal to the screw gear.Bunching was visible along the graft cover.There was no further deformation evident to the delivery system.The reported deformation was confirmed through analysis.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• 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
• MDR Report Key: 10654594
• MDR Text Key: 210630450
• Report Number: 9612164-2020-03847
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P100021
• 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: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2022
• Device Model Number: ETLW1616C124EE
• Device Catalogue Number: ETLW1616C124EE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 10/30/2020; 12/03/2020
• Supplement Dates FDA Received: 11/26/2020; 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 80