MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDO ANCHOR SYSTEM - HELI-FX AAA; ENDOVASCULAR SUTURING SYSTEM

Model Number	HG-16-62-28
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2018
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 endo anchoring system was used prophylactically in conjunction with an endurant stent graft system during the endovascular treatment of an abdominal aortic aneurysm.It was reported during the index procedure after the first endo anchor had been deployed and when the guide was straightened, difficulty was noted when attempting to retract the applier.The applier was removed with the guide and upon inspection of the guide the tip end was observed to be deformed.A second guide was opened however during deflection (following the ifu) a snap noise was heard and the guide ceased to deflect any further.A third sg-64 guide was then used with no further issues noted and the procedure completed successfully.Per the physician the cause of the event is undetermined.No additional clinical sequalae were reported and the patient is fine.
Additional Manufacturer Narrative
Device evaluation summary: the guide and dilator were returned for analysis.Severe deformation was visible to the inner curve of the guide tip.There was partially exposed braid wire visible inside the tip.The tip was slightly oval in shape with delamination visible inside the tip.The tip deflected on rotation of the control knob with no abnormality noted.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO ANCHOR SYSTEM - HELI-FX AAA
• Common Device Name: ENDOVASCULAR SUTURING SYSTEM
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8051492
• Report Number: 2953200-2018-01569
• Device Sequence Number: 11175988
• Product Code: OTD
• UDI-Device Identifier: 00763000025267
• UDI-Public: 00763000025267
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2019

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: 06/27/2020
• Device Model Number: HG-16-62-28
• Device Catalogue Number: HG-16-62-28
• Device Lot Number: 0009211630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1