MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 18 HYDROCOIL PUSHABLE 6MM X 6CM; VASCULAR EMBOLIZATION DEVICE

Model Number	45-280606
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Codes	Therapeutic Response, Decreased (2271); No Code Available (3191)
Date of Event	10/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.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 not returned to the manufacturer for analysis.The root cause could not be determined.
Event or Problem Description
It was reported that treatment was performed for a gastroduodenal artery (gda) bleed.The azur pushable coil did not form in the gda.Two subsequent coils were successfully deployed in the treatment site without any issues.The pushable coil was unable to be removed or repositioned.The coils did not stop the bleeding.A laparotomy was then performed to treat the initial gda bleed.
Additional Manufacturer Narrative
Images provided by the customer were analyzed by mv's product safety physician.Multiple embolic coils were visualized.Some of the coils had a normal secondary shape and some of coils did not, which is consistent with the complaint that stated the azur pushable coils did not shape properly and the azur cx detachable coils did shape properly.It is possible that the azur pushable coils were not properly sized for the vessel (may have been over-sized) which kept the coils from maintaining or achieving its appropriate secondary shape.This may have led to the eventual inability of the treatment vessel to be occluded properly.Per the azur product sme and azur product ifus, the azur pushable coils and azur cx detachable coils have different sizing parameters.

• Brand Name: AZUR 18 HYDROCOIL PUSHABLE 6MM X 6CM
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 9625001
• Report Number: 2032493-2020-00015
• Device Sequence Number: 2773876
• Product Code: KRD
• UDI-Device Identifier: 00810170012228
• UDI-Public: (01)00810170012228(11)181002(17)210930(10)18100254B
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K071939
• 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): 12/24/2019

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: Other
• Device Expiration Date: 09/30/2021
• Device Model Number: 45-280606
• Device Catalogue Number: 45-280606
• Device Lot Number: 18100254B
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/24/2019
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR