MAUDE Adverse Event Report: MICROVENTION, INC. VIA-17 MICROCATHETER; PERCUTANEOUS CATHETER

Model Number	VIA-17-154-45-MVI2
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	06/30/2021
Type of Reportable Event	Serious Injury
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 has not yet been returned to the manufacturer for evaluation.Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use (ifu) identifies aneurysm rupture as a potential complication associated with use of the device.
Event or Problem Description
It was reported that the via catheter had been placed in the desired position.Upon advancement of the web within the catheter, the via jumped towards the aneurysm wall and ruptured the aneurysm.The bleeding was stopped by leaving the system in place, implanting embolization coils and opening the web.The patient was reported to be doing well without deficit.
Additional Manufacturer Narrative
The device is no longer considered to be returning to the manufacturer for evaluation.The alleged product complaint cannot be confirmed.
Additional Manufacturer Narrative
H10: device evaluation summary: the investigation of the returned pusher and via17 microcatheter revealed a kink at the gold connector to hypotube transition, a significant kink in the hypotube 25 cm from the proximal end of the pusher, and bends in the pusher at 69 cm and 77 cm from the proximal end of the pusher.The pusher successfully advanced through the returned via17 with increased force from friction due to the bends and kinks in the pusher; however, a "jumping" motion reported in the complaint was not observed.As the "jumping" phenomenon was unable to be reproduced, the cause for the phenomenon could not be determined.The bends and kink in the pusher likely occurred during or post-procedure as web production inspects devices 100% for such irregularities.The bends and kink contributed to increased advancement forces but could not be identified as the direct cause for the reported "jumping" as the phenomenon was unable to be reproduced.Provided images showed the ruptured aneurysm, which was visible by extravasation of contrast, cessation of hemorrhaging, and final stable aneurysm with web and coils.No notable conditions were found regarding the returned via microcatheter that would have caused or contributed to the reported event.
Additional Manufacturer Narrative
Correction: g3 (initial event awareness date).

• Brand Name: VIA-17 MICROCATHETER
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12243025
• Report Number: 2032493-2021-00296
• Device Sequence Number: 3807846
• Product Code: DQY
• UDI-Device Identifier: 00842429106440
• UDI-Public: (01)00842429106440(11)210303(17)240229(10)21030313F
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K150894
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/01/2021

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: 02/29/2024
• Device Model Number: VIA-17-154-45-MVI2
• Device Catalogue Number: VIA-17-154-45
• Device Lot Number: 21030313F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 08/31/2021; 09/16/2021; 06/30/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 08/31/2021; 10/13/2021; 10/14/2021
• 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