MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY 27 MICROCATHETER

Model Number	MC272156S
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Codes	Embolism (1829); Granuloma (1876); Neurological Deficit/Dysfunction (1982)
Date of Event	10/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history record indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The device was discarded at the user facility; therefore, a product analysis could not be performed.The root cause cannot be determined.
Event or Problem Description
It was reported that during treatment of a cavernous ophthalmoplegic aneurysm in the right internal carotid artery, a non-microvention flow diverter was delivered through the headway 27 microcatheter and implanted.Treatment was reported to be successful; however, the patient's condition worsened after 24 hours.An mri demonstrated granulomas and complete occlusion of the right hemisphere.The granulomas were surgically removed from the patient and analysis of the granulomas revealed particles of ptfe.The patient was transferred to rehabilitation.No further information has been provided about the patient's current condition.
Additional Manufacturer Narrative
Corrected data: (date of event) - the sales representative informed microvention on 7/9/19 that the actual date of occurence is 10/20/2018, not 2/13/19 as initially reported.Device evaluated by mfr: the device, as reported in the initial mdr, was not returned, but additional findings were added to the invesitgation: the complaint noted that the granulomas excised from the patient under microscopic examination contained what appeared to be particles of ptfe.The customer did not supply these microscopic images, and there was no material analysis completed by the customer that confirmed the particles were ptfe.Additionally, multiple devices were used during the procedures, some of which also may have pfte coatings in addition to the headway.As a result of the headway device not being available for analysis, other potential sources of ptfe being used during the procedure, and the lack of confirmation by material analysis that particles are made of pfte, the headway device being the source of the ptfe like particles cannot be verified.

• Brand Name: HEADWAY 27 MICROCATHETER
• Common Device Name: MICROCATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8476448
• Report Number: 2032493-2019-00072
• Device Sequence Number: 19145871
• Product Code: DQY
• UDI-Device Identifier: 00811425021385
• UDI-Public: (01)00811425021385(11)180426(17)210331(10)18042612L
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2019

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: 03/31/2021
• Device Model Number: MC272156S
• Device Catalogue Number: MC272156S
• Device Lot Number: 18042612L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 07/11/2019
• 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: Hospitalization; Required Intervention; Disability
• Patient Age: 63 YR