MAUDE Adverse Event Report: MEDTRONIC NV AXIUM HELIX; DEVICE, EMBOLIZATION, VASCULAR

Model Number	QC-1.5-3-HELIX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the axium coil (model: qc-1.5-3-helix lot: a400598) was returned for analysis within a shipping box.The echelon-10 micro catheter (pli-20) will not be returned for analysis as it was discarded at the site.The echelon-10 micro catheter has a labeled id (inner diameter) of 0.017¿.Per the axium ifu (instructions for use), axium bare coils should be delivered through a micro catheter with a minimum inside diameter of 0.0165¿.Therefore, the echelon-10 micro catheter was found to be compatible for use with the axium coil.The axium pushwire was found to be bent and broken at ~3.7cm from the proximal end with the release wire extending ~45.0cm.Under the microscope, the coin was not found to be located against the lumen stop, the coil shield was found to be damaged (stretched), and the implant coil was found to be detached and missing.No other anomalies were observed.The axium coil could not be used for resistance testing with an in-house micro catheter due to its damaged condition.The axium coil was returned for analysis without the echelon-10 micro catheter used in the event as it was discarded at the site; therefore, conformance to specifications could not be determined.The axium pushwire was found to be bent and broken.The coil shield was found to be damaged (stretched) and the implant coil was found to be detached and missing.The axium coil could not be used for resistance testing with an in-house micro catheter due to its damaged condition.Based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ could not be confirmed.It is possible that the coil shield became damaged due to the movement of the coil against the reported resistance.It is possible that the axium pushwire became bent and broken with the implant coil subsequently detaching from the pushwire during shipping back to medtronic for evaluation as the customer did not report the implant coil detachment at the time of the event.However, the cause for the damages could not be determined.Possible contributing factors to ¿coil resistance/stuck in catheter¿ include the use of an incompatible device for delivery, severely tortuous patient anatomy, failure to hydrate the coil prior to use, and lack of continuous flush during delivery.The echelon-10 micro catheter was found to be compatible for use with the axium coil, the customer reported hydrating the axium coil prior to use, the patient¿s vessel tortuosity was ¿normal¿, and a continuous flush was maintained during delivery.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the coil could not pass at the proximal end of the microcatheter due to resistance.It was noted that the coil pushed out from the introducer sheath smoothly.There was reportedly no damage to the coil and catheter observed.It was stated the hydration check in vitro was normal.As a result, the coil was replaced and the surgery was completed as normal.The patient was undergoing surgery to treat an unruptured, saccular aneurysm with a max diameter of 3mm and a neck diameter of 2mm.It was noted the vessel tortuosity was normal.There were no patient symptoms associated with the event.The devices were prepared as indicated in the ifu.Yes, the continuous flushed was administered during the procedure.As the operation continued, the replacement of the spring coil can be normally delivered into the microcatheter and discarded postoperatively.

• Brand Name: AXIUM HELIX
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MEDTRONIC NV; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8330024
• Report Number: 2029214-2019-00112
• Device Sequence Number: 1634879
• Product Code: KRD
• UDI-Device Identifier: 00847536017184
• UDI-Public: 00847536017184
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/11/2019

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: 01/13/2020
• Device Model Number: QC-1.5-3-HELIX
• Device Catalogue Number: QC-1.5-3-HELIX
• Device Lot Number: A400598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR