MAUDE Adverse Event Report: MEDTRONIC IRELAND TALENT OCCLUDER; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	OCL12US
Medical Device Problem Codes	Leak/Splash (1354); Difficult to Remove (1528); Malposition of Device (2616)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
An endurant ii aui stent graft system and a talent occluder were implanted in a patient for the endovascular treatment of a 5.7 cm in diameter abdominal aortic aneurysm.The vessel morphology was reported as very tight and calcified aortic bifurcation.The right iliac artery measured between 6 mm and 7 mm in diameter.The left iliac artery measured from between 4 mm and 5 mm in diameter to between 5 mm and 6 mm in diameter.The proximal aortic neck measured 24 mm in diameter.There was severe left iliac calcification.There was moderate to severe right iliac calcification.There was mild calcification at the proximal aortic neck.The patient had a wide and conical proximal aortic neck.The left renal artery was the lowest renal artery and the right renal artery was atrophic.It was reported that endurant aui was advanced up to the left renal stent.The endurant aui was initially deployed and implanted at the intended landing zone.However, when the delivery system was being removed, there were difficulties removing the delivery system.The graft cover was below the area of calcified/tight aorta and the spindle and taper tip could not be retracted back to the graft cover.The physician advanced the delivery system above the renal arteries and could reseat the taper/spindle to the graft cover and the delivery system removed from the patient.During the manipulation of the delivery catheter the endurant aui was inadvertently pulled down.An angiogram revealed an unknown endoleak either type ia endoleak or type iv endoleak.The physician elected implant an endurant aortic cuff, without confirming the type of endoleak due to the patient¿s creatinine level of 1.6.The final angiogram showed no endoleak present.It was reported that the talent occluder device was advanced attempting to get close to the left internal iliac artery.The talent occluder was deployed and an angiogram from the sheath was performed.The angiogram revealed the talent occluder was too close to the origin of the left internal iliac artery.The physician wanted to push the talent occluder slightly proximal.The physician was inadvertently handed the talent occluder tapered tip dilator instead of a blunt tip dilator.The talent occluder taper tipped dilator was advanced through the sheath and when it exited the sheath the taper tipped dilator exited the distal common iliac artery.A retrograde angiogram demonstrated contrast outside the vessel due to vessel perforation.The physician implanted a 10mm coil distal to the talent occluder device however there was still contrast extravasation outside the vessel.The physician made the decision to cover the left internal artery with a 10mm talent occluder and the vessel perforation was covered.Per the physician, the cause of the removal difficulties resulting in stent graft movement and type ia endoleak was due to patient anatomy.Per the physician, the cause of the vessel perforation was due to user error, the wrong part was given to the physician.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TALENT OCCLUDER
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6557392
• Report Number: 2953200-2017-00764
• Device Sequence Number: 749652
• Product Code: MIH
• UDI-Device Identifier: 00613994573148
• UDI-Public: 00613994573148
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/14/2019
• Device Model Number: OCL12US
• Device Catalogue Number: OCL12US
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2017
• Supplement Date Received by Manufacturer: 04/17/2017
• Initial Report FDA Received Date: 05/10/2017
• Supplement Report FDA Received Date: 10/03/2017
• 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: 70 YR