MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 35 CX DETACHABLE; VASCULAR EMBOLIZATION DEVICE

Model Number	45-751019
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with this 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 analysis.The investigation is ongoing.
Event or Problem Description
It was reported that during embolization treatment of the internal iliac artery, the physician observed that the implant was larger than it should be and removed it.The implant unraveled during removal.There was no patient harm reported or intervention.
Additional Manufacturer Narrative
A search for non-conformances associated with this 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 analysis.The investigation is ongoing.
Event or Problem Description
It was reported that during embolization treatment of the internal iliac artery, the physician observed that the implant was larger than it should be and removed it.The implant unraveled during removal.There was no patient harm reported or intervention.
Additional Manufacturer Narrative
The investigation of the returned coil system found the implant stretched at the proximal end and to separated from the pusher.The monofilament profile is a stretched tail shape and the implant loops were measured to be "20mm" (10mm x 19cm = expected coil side).The length of the implant was unable to be measure due to the condition of the proximal loop.The implant coil is confirmed to be larger than 10mm x 19cm.The findings from the investigation were communicated to quality management.
Additional Manufacturer Narrative
H11 - corrections: h6 - component code - remove 3157.H6 - investigation finding codes - remove 3211 and 3252.H6 - investigation finding codes - add 4211.H6 - investigation conclusion codes - remove 4315.H6 - investigation conclusion codes - add 23.

• Brand Name: AZUR 35 CX DETACHABLE
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• 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: 13312274
• Report Number: 2032493-2022-00024
• Device Sequence Number: 1701329
• Product Code: KRD
• UDI-Device Identifier: 00812636021072
• UDI-Public: (01)00812636021072(11)190507(17)240430(10)1905075J2
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2021

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: 04/30/2024
• Device Model Number: 45-751019
• Device Catalogue Number: 45-751019
• Device Lot Number: 1905075J2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 02/24/2022; 02/24/2022
• Initial Report FDA Received Date: 01/21/2022
• Supplement Report FDA Received Date: 03/25/2022; 03/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2019
• 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
• Patient Age: 76 YR
• Patient Sex: Male