MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM HELIX; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	QC-3-4-HELIX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that three axium coils experienced great resistance in the middle section of the echelon microcatheter.Several attempts were made to deliver the coil, but they were unsuccessful.It was reported two of the coils were damaged.A replacement product was used in the coil's place.It was indicated that all devices were preparedas per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the left clinoid segment with a max diameter of 6.4 mm and a 3.3 mm neck diameter.It was noted the patient's blood flow and vessel tortuosity were normal.Additional information received reported coil qc-2-3-helix lot #: a624586 was not involved in this event.
Additional Manufacturer Narrative
Device evaluated by mfr: product analysis #276738303.Equipment used: video inspection system (m-78210), ruler 200cm (m-83361), camera (panasonic lumix dmc-zs5).Drawing(s) referenced: n/a.As found condition: the axium coil was returned for analysis within a shipping box; within a plastic bio-pouch the echelon-10 micro catheter used in the event was not returned.Therefore, device analysis could not be performed and conformance to specifications could not be determined.The echelon-10 micro catheter has a labeled id (inner diameter) of 0.017¿.Per the axium coil instructions for use (ifu): axium bare coils are compatible for use with micro catheters with a minimum id of 0.0165¿.Therefore, the echelon-10 micro catheter was found compatible for use with the axium coil.Visual inspection/damage location details: the axium implant coil was returned without its introducer sheath.Therefore, any contributing factors from the introducer sheath could not be assessed.The axium pushwire was found to be broken between positive load indictor and break indicator.In addition, the axium pushwire was appeared to be bent at ~14.2cm and ~97.5cm from broken end.The axium implant coil was found to be detached from pushwire and not returned for analysis.Therefore, any contributing factors from the implant coil could not be assessed.In addition, the shield coil was found damaged and stretched.No other anomalies were observed.Testing/analysis: the axium coil could not be used for resistance testing with an in-house micro catheter due to its damaged condition.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/ stuck in catheter¿ was confirmed and the root cause could not be determined.Possible causes for coil resistance in catheter are, but not limited to, use of an incompatible device for delivery, severely tortuous patient anatomy, failure to hydrate the concerto coil prior to use, and lack of continuous flush during delivery.The devices were prepared according to the instructions for use (ifu) and the patient¿s vessel tortuosity was normal.The echelon-10 micro catheter was found compatible for use with the axium coil.There was no non-conformance to specifications identified that led to the resistance issue.(nikkhs2 2022-05-09).If information is provided in the future, a supplemental report will be issued.

• Brand Name: AXIUM HELIX
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 14574748
• Report Number: 2029214-2022-00930
• Device Sequence Number: 5041445
• Product Code: KRD
• UDI-Device Identifier: 00847536017559
• UDI-Public: 00847536017559
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/02/2022

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: 10/26/2020
• Device Model Number: QC-3-4-HELIX
• Device Catalogue Number: QC-3-4-HELIX
• Device Lot Number: A546790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2022
• Initial Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 67 KG