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

Model Number ETBF3616C145EJ

Device Problems Device Difficult to Setup or Prepare (1487); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intimal Dissection (1333); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Hypovolemic Shock (1917)

Event Date 02/18/2020

Event Type  Injury  

Manufacturer Narrative

Additional information: it was confirmed that it was unknown how the delivery system of etbf3616c166ej broke, but it was noted to be kinked and bent.It was reported that the device was checked after the procedure and was able to deploy even with the kink.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant ii bifurcate stent graft was implanted in the endovascular treatment of 67.9 mm abdominal aortic aneurysm.During the index procedure, when an attempt was made to advance the main body's delivery system of etbf3616c166ej through the external iliac artery, the delivery system broke due to the severe tortuosity of the vessel.The use of this device was then abandoned.Another endurant bifurcate device etbf3616c145ej of another size was chosen and the device of inserted along with a 20fr non-mdt sheath, it was noted that the procedure was progressing smoothly but the patient's blood pressure dropped significantly.After this, the sheath was removed.Imaging was then performed and it was confirmed the right external iliac artery had torn.An attempt was made to cover the torn area with a 12mm by 12cm non-mdt excluder leg but the guidewire came off at this time.An attempt was made to advance the guidewire again but failed.A hemorrhage developed in the abdominal cavity and the patient went into hypovolemic shock.An emergency laparotomy was performed with a midline incision and the torn right external iliac artery was sutured.It was judged that this artery could not be reconstructed so a fem-fem bypass was performed and the procedure was completed.As per the physician the cause of the event was anatomy and due to severe tortuosity of the external iliac artery.No additional clinical sequalae were provided and the patient is fine.

Manufacturer Narrative

Film evaluation summary: the reported device breakage event could not be confirmed on the films provided.The reported vessel rupture with subsequent fem-fem bypass surgery was confirmed on the films provided.It appears most likely that the highly tortuous and calcified iliac anatomy was a contributory factor in the reported vessel rupture event.The cause of the incomplete expansion of the suprarenal stents could not be determined.Lack of pre-implant ct¿s did not allow for a thorough assessment of the pre-implant anatomy so it is unknown if there was narrowing of the aortic neck in this area.Analysis of the returned ct slices and still angiograms did not reveal any obvious out of specification stent graft integrity issues.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9738701
• MDR Text Key: 188747071
• Report Number: 9612164-2020-00835
• 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: 08/20/2020

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: 12/10/2021
• Device Model Number: ETBF3616C145EJ
• Device Catalogue Number: ETBF3616C145EJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 02/21/2020
• Supplement Dates Manufacturer Received: 02/26/2020; 07/23/2020
• Supplement Dates FDA Received: 03/24/2020; 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 86 YR