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

Model Number ETBF3216C166EE

Device Problems Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907); Device Contamination with Chemical or Other Material (2944)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/15/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

An endurant ii stent graft system was implanted in the patient for the endovascular treatment of an 84mm diameter aaa.During the procedure, it was reported the etbf3216c166ee was inserted using a high support guidewire and an 20fr vascular introducer.The device was then released under fluoroscopy, taking care not to cover the renal arteries.It was reported there were difficulties encountered while attempting to deploy the stent graft and the spindle would not release the suprarenal stents.After several attempts the physician decided to perform open surgery.Once the endoprosthesis was removed from the patient it was noted that there was a small plastic ring caught on the stent which was preventing the device from deploying.It was reported that a surgical graft was placed during the open repair but the patient had bled a lot and after removing the clamps from the aorta the physician noticed that there was no pulse in the aorta.The patient was pronounced dead in the procedure room.Per the physician, the cause of the event was caused by a damaged device and failure to release the graft.No additional clinical sequelae were reported and the patient has expired.

Manufacturer Narrative

Film evaluation: the reported deployment difficulties were confirmed on the films provided; however, the cause of the event could not be fully determined.Lack of pre-implant ct¿s did not allow for a thorough assessment of the pre-implant anatomy.It is likely that the noted angulated aortic neck contributed to the difficulties observed in releasing the suprarenal stents.A device issue with possible presence of a ring restricting release of the suprarenal stents cannot be ruled out as a potential cause.However, the delivery system was discarded and a product investigation could not be performed.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.

Manufacturer Narrative

Product analysis five photos were received from the account.The photos show the device with the partially deployed graft post removal from the patient.It appears the graft cover tip material had detached.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.

Manufacturer Narrative

Continued from h9: (b)(6).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 TR
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 11804922
• MDR Text Key: 249925746
• Report Number: 9612164-2021-01848
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/09/2021

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: 09/11/2021
• Device Model Number: ETBF3216C166EE
• Device Catalogue Number: ETBF3216C166EE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2021
• Initial Date Manufacturer Received: 04/15/2021
• Initial Date FDA Received: 05/11/2021
• Supplement Dates Manufacturer Received: 05/12/2021; 06/09/2021; 06/18/2021
• Supplement Dates FDA Received: 06/09/2021; 06/24/2021; 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: SEE H10
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 83 YR
• Patient Weight: 80