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

Model Number ESBF3214C103EE

Device Problems Activation, Positioning or Separation Problem (2906); Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

An endurant iis stent graft system was implanted in the patient for the endovascular treatment of an unknown sized abdominal aortic aneurysm.It was reported that during the index procedure, the bifurcate stent graft was introduced via the rightside.After checking the level of the lower kidney, the bifurcate was deployed until release of the contralateral gate.The physician the proceeded to release the suprarenal stents and instead of the spindle moving proximally, it moved distally.The physician decided to manually dismantle the device to solve the issue but this did not resolve it.The physician then tried to insert an introducer sheath to push the spindle proximally but this also did not resolve the issue.The physician then tried to inflate a reliant balloon in the area to attempt to exert a downward pull while also pushing the whole device proximally.However, there was no resolution as the spindle tube only flexed.At this point the physician brought the sheath back over the spindle to make it more rigid and moved the balloon by inserting it into the stent graft body and inflated it while positioned on the flow divider.This successfully pushed the system proximally, managing to free the suprarenal stents inside the sheath and resolve the event.As per the physician, the cause of the event was related to an unknown component in the delivery system.No additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Product analysis conclusion; the reported difficulty to release the suprarenal stents event was confirmed on the still image provided.The cause of the event appeared to be due to an additional piece on the spindle tubing which has captured the suprarenal stents.A device issue cannot be ruled out as a potential cause.The delivery system is pending return for analysis and the results will be summarized in a separate report.B:5 additional information received.It was reported that on retrieval of the delivery system from the patient a ''foreign material¿ was noted inside the sleeve which may have prevented the suprarenal stents from opening correctly.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 conclusions; the reported difficulty to release the suprarenal stents was not assessed on the pre-implant films received.Lack of procedural angiogram showing the event were not provided.Analysis of the returned films did not reveal any obvious anatomical anomalies that may have led to the reported suprarenal stent deployment issues.The bifurcate device appeared to be appropriately sized within the recommended 10-20% for implantation in the patient¿s aortic neck.A device issue cannot be ruled out as a potential cause.The delivery system was returned with the handle and back-end disassembled.The graft loading tool was visible on the device at the sleeve.The reported event 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.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 IIS 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: 10378686
• MDR Text Key: 202031541
• Report Number: 9612164-2020-02918
• 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: 11/02/2020

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: 12/09/2021
• Device Model Number: ESBF3214C103EE
• Device Catalogue Number: ESBF3214C103EE
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/03/2020
• Initial Date Manufacturer Received: 07/22/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 08/07/2020; 10/06/2020
• Supplement Dates FDA Received: 09/01/2020; 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1