MAUDE Adverse Event Report: MICROVENTION, INC. AZUR-35 PUSHABLE HYDRO; VASCULAR EMBOLIZATION DEVICE

Model Number	45-251014
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Ischemia (1942); Pain (1994)
Date of Event	04/16/2020
Type of Reportable Event	Serious Injury
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 not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies coil migration or misplacement, ischemia, and neurological deficits as potential complications associated with use of the device.
Event or Problem Description
It was reported that peripheral coil embolization was performed for a splenic artery aneurysm.Post-deployment images demonstrated migration of an embolization coil to the splenic hilum.The patient experienced increasing pain over the following two weeks, which was managed with medications.Subsequent ct imaging taken 17 days post-procedure demonstrated segmental splenic infarction.The patient's current status has not been provided.

• Brand Name: AZUR-35 PUSHABLE HYDRO
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 10752776
• Report Number: 2032493-2020-00310
• Device Sequence Number: 3196370
• Product Code: KRD
• UDI-Device Identifier: 00810170012556
• UDI-Public: (01)00810170012556(11)180717(17)210630(10)18071752E
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K071939
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2020

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 Expiration Date: 07/17/2018
• Device Model Number: 45-251014
• Device Catalogue Number: 45-251014
• Device Lot Number: 18071752E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 10/28/2020
• 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: Disability
• Patient Age: 40 YR