MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDO ANCHOR SYSTEM - HELI-FX AAA; LASER THERAPY PRODUCT

Model Number	HG-16-62-28
Medical Device Problem Codes	Device Damaged by Another Device (2915); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A heli-fx guide was used prophylactically in conjunction with a medtronic stent graft for treatment of a patient.It was reported that during the index procedure the evar was performed without complication.The heli-fx system successfully implanted one endoanchor.While attempting to orient the heli-fx guide to deploy the second endoanchor, the heli-fx guide was caught up on the proximal stent graft edge while being deflected.It was observed that the heli-fx guide lost its ability to deflect and correctly orient the endoanchor.This heli-fx guide was removed and replaced with a new heli-fx guide which successfully implanted a further 7 endoanchors without complication.As per the physician the cause of the event was due to user error as the physician continued to deflect the guide after it was caught on the graft.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary the exact cause of the reported implantation difficulties, inability to deflect the tip and correctly orient the endoanchor, could not be determined from the pre-implant films returned.Films during implant were not available and images during the event could not be assessed.A pre-implant 3d-ct film report revealed that the patient had an hour-glassed shaped proximal neck, that ranged in diameter from 39 ¿ 32 ¿ 28 ¿ 36mm along the 3cm length.The neck contained moderate levels of thrombus with scattered calcification, and minimal neck angulation was visible in the returned images.Analysis of the returned films did not reveal any clear anatomical anomalies that could explain the reported event.It is possible that this was user error; continuing to deflect the guide after it was caught on the stent graft.A device issue also cannot be ruled out; however, the device was discarded and could not be analyzed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO ANCHOR SYSTEM - HELI-FX AAA
• Common Device Name: LASER THERAPY PRODUCT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7435534
• Report Number: 2953200-2018-00551
• Device Sequence Number: 196873
• Product Code: OTD
• UDI-Device Identifier: 00763000025267
• UDI-Public: 00763000025267
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K140036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2018

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: 01/03/2020
• Device Model Number: HG-16-62-28
• Device Catalogue Number: HG-16-62-28
• Device Lot Number: 0008896057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Initial Date Received by Manufacturer: 03/20/2018
• Supplement Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 05/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR