MAUDE Adverse Event Report: MICROVENTION, INC. AZUR CX 18D-LONGER; PERIPHERAL

Model Number	45-781032-L
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during embolization of a pseudoaneurysm the third coil used in the case became stuck, unraveled with a portion of the coil remains in the patient.The first azur cx coil was followed by a competitor pushable coil which experienced resistance in a competitor catheter.The physician pushed out the competitor pushable coil out of the catheter and then attempted to place an azur coil behind it; however, it got tangled up in the coil mass.When the physician attempted to retract the azur coil, it became stuck and began to unravel.The physician snared some of the coil out.A portion of the unraveled coil remains in the patient¿s body, from the sma to the aorta and down near the femoral access point.The procedure outcome was successful.The patient is reported as stable.
Additional Manufacturer Narrative
A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Event or Problem Description
Additional information received: the pseudoaneurysm was in the sma.The unraveled coil went from sma down near the common femoral artery.The coil strand was glued in place.No additional meds noted.
Additional Manufacturer Narrative
The investigation of the returned coil system found the implant coils to be stretched, broken, separated from the pusher, and tangled on the distal end of the snare device.The pusher was not returned for evaluation.The distal portion of the severed implant was also not returned for evaluation as it remained in the patient as described in the reported event.The implant's monofilament showed a tensile break shape at the tip, which is consistent with the device experiencing excessive force that exceeded the strength of the monofilament causing the implant to separate from the pusher.This condition is consistent with the coil becoming stuck or experiencing friction during repositioning within the target site (i.E.Stuck on previously implanted coils or the tip of the microcatheter).The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: AZUR CX 18D-LONGER
• Common Device Name: PERIPHERAL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15974256
• Report Number: 2032493-2022-00549
• Device Sequence Number: 12226984
• Product Code: KRD
• UDI-Device Identifier: 00810170018350
• UDI-Public: (01)00810170018350(11)220630(17)270531(10)0000216523
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K151358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 45-781032-L
• Device Catalogue Number: 45-781032
• Device Lot Number: 0000216523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2022
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 01/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown