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

Model Number	OCL20US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	04/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of medical devices: information references the main component of the system.Other relevant device(s) are: product id: ocl16us, serial/lot #: (b)(4), ubd: 20-mar-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A talent occluder device was implanted in a patient during the endovascular treatment of a unknown sized abdominal aortic aneurysm.It was reported that during the index procedure, the physician implanted the talent occulder into the left common iliac artery.A retrograde injection was done to see if the left common iliac artery had been occluded which then showed extravasation into the retroperitoneal space.The physician placed a 16mm occluder plug to stop the bleeding, however, it did not work.A flank incision was made to visualize the left common iliac artery and the 20mm talent occluder plug was removed from the vessel as it had torn through the artery.The 16mm occluder plug was also removed.Through some difficulty due the damaged vessel, prolene sutures were sown over the artery to stop the bleeding and homeostasis was achieved.At the end of the procedure a final angiogram was performed and no extravasation was apparent in the retroperitoneal space.As per the physician, the cause of the event was anatomy related due to the calcification in the left common iliac.It was noted by the physician that there is a possibility that a dissection was created in the iliac as the occluder was placed, and it tore through the entire vessel.A femoral-femoral bypass was then performed after the aui and it was observed that the femoral arteries were also in bad condition and hard to sew due to disease and calcification.No additional clinical sequela was reported and the patient is fine.

• 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: 7521473
• Report Number: 2953200-2018-00730
• Device Sequence Number: 1704171
• Product Code: MIH
• UDI-Device Identifier: 00613994573063
• UDI-Public: 00613994573063
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/15/2020
• Device Model Number: OCL20US
• Device Catalogue Number: OCL20US
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 05/17/2018
• 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: 70 YR