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	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2019
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 applier and guide were used for the endovascular treatment of a patient.  it was reported that during the index procedure, after the physician implanted, the first endoanchor, the guide and the applier became deformed, with the wires becoming exposed.The physician was able to deflect the guide catheter but was not able to torque the entire sheath.It was also reported that the applicator failed.Per the physician the cause of the event was anatomy related, due to the tortuosity of the iliac arteries.However, as per the physician, the tortuosity does not explain the mechanical failure regarding the structural integrity of the sheath which no doubt contributed to loss of maneuverability.The physician also stated that the patient had no harm as a result of this malfunction due to the fact that the sheath was constrained within another guide sheath.No clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Device evaluation summary: a review of the device manufacturing documentation did not reveal any anomalies.It was reported that the physician experienced difficulties torquing the guide resulting in the failure of the structure of the guide.Analysis of the guide confirmed the guides outer pebax layer, braid wire and ptfe liner were torn and damaged.The kevlar remained intact.A photo of the device received from the account confirmed the damage to the guide.The twisting evident at the tear site indicated that the tip of the guide may have been deflected as the device was torqued; however as procedural films were not provided this cannot be confirmed.It is possible that due to the tortuous nature of the iliac arteries the guide may have been over torqued during advancement and/or positioning.Advancement and retraction of the applier within the guide may have contributed to the deformation.It appears the cause of the deformation to the guide was likely related to the patient anatomy.This failure mode will continue to be monitored and trended.No additional preventive and/or corrective actions are required.Film evaluation summary: one (1) photo was received from the account.The photo captured severe damage to the guide.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: 8507950
• Report Number: 2953200-2019-00489
• Device Sequence Number: 1062646
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2019

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: 12/11/2019
• Device Model Number: HG-16-62-28
• Device Catalogue Number: HG-16-62-28
• Device Lot Number: 0008916707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 06/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 69