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

Model Number	ETBF2516C166E
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	12/06/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment of 4.6cm abdominal aortic aneurysm.The aortic neck was 19mm proximally and 23 mm in diameter distally with 20 degree of cranial angulation.It was reported the patient returned for follow-up ct approximately 2 years post the index procedure.A type ia endoleak and migration of the bifur 10mm below renals was observed.The device had been previously confirmed as deployed at the target location in the one month follow up ct post the index procedure.The physician has elected to perform secondary intervention.Per the physician the cause of the event is undetermined.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
Film evaluation summary; the exact cause of the stent graft migration leading to the proximal type i endoleak could not be determined from the films provided.Pre-implant ct¿s confirmed that the patient had a 45mm max diameter infrarenal aaa.The neck diameter just below the lowest left renal artery measured ~19mm, 10mm lower was 22mm, and the infrarenal neck angulation measured ~50 deg a-p.Ct¿s returned at 1-month, 6, 14, and 26 month¿s post-implant revealed that the bifurcate had migrated ~10mm during the implant duration, and the bifurcate proximal od had increased from 20 ¿ 25mm with continued loss of radial apposition with the aorta.The aortic body and infrarenal neck angulation also increased during this duration from ~45 deg to 60 deg a-p; relative to the iliac limbs.A type ii endoleak was initially seen at 1-month, and beginning at the 14 month follow-up a proximal type i endoleak with aaa expansion from 45 ¿ 49mm was seen.The cause of the aaa expansion was most likely due to both the type i and type ii endoleak.The cause of the migration appe ared to be due to disease progression (neck dilatation) and aneurysm morphology changes (increased neck angulation).Additional information received 22-jan-18 reported that the physician placed a cuff and covered stents in both renal arteries as snorkels.The seal was extended to sma.The aneurysm was successfully sealed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7177745
• Report Number: 2953200-2018-00050
• Device Sequence Number: 16410795
• Product Code: MIH
• UDI-Device Identifier: 00613994991270
• UDI-Public: 00613994991270
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2017
• Device Model Number: ETBF2516C166E
• Device Catalogue Number: ETBF2516C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Initial Date Received by Manufacturer: 12/15/2017
• Supplement Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 02/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 64