MAUDE Adverse Event Report: MICROVENTION, INC. SOFIA 5F 125 CM STR; PERCUTANEOUS CATHETER

Model Number	DA5125ST
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	03/04/2020
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 was not returned to the manufacturer for analysis.The root cause cannot be determined,.
Event or Problem Description
It was reported that stent-assisted coiling was performed in (b)(6) 2019 for a ruptured a-com aneurysm.Three months after the procedure, coiling of residual aneurysm was attempted and the sofia was advanced through the pre-existing stent.A follow-up angiogram demonstrated a vessel dissection in the arterial wall behind the pre-existing stent after the sofia was put into position within it.Another stent was implanted within the pre-existing stent and subsequent angiography demonstrated successful treatment of the dissection.There was no reported clinical sequela.

• Brand Name: SOFIA 5F 125 CM STR
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 9925513
• Report Number: 2032493-2020-00084
• Device Sequence Number: 3296701
• Product Code: DQY
• UDI-Device Identifier: 00810170019234
• UDI-Public: (01)00810170019234(11)191219(17)221130(10)191219567
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2020

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?: No
• Operator of Device: Other
• Device Expiration Date: 11/30/2022
• Device Model Number: DA5125ST
• Device Catalogue Number: DA5125ST
• Device Lot Number: 191219567
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 04/03/2020
• 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