MAUDE Adverse Event Report: ENDOSHAPE, INC. MEDUSA MULTI-COIL; VASCULAR EMBOLIZATION DEVICE

Model Number	MMC-122
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	12/10/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device implanted successfully.No problem reported with use of device.Deep vein thrombosis is a known risk with venous embolization.Device was not explanted.
Event or Problem Description
Patient treated with mmc-122 embolization device for venous insufficiency on (b)(6) 2015.Deep vein thrombosis diagnosed on (b)(6) 2015.Patient given warfarin and followed for two weeks.No permanent impairment.

• Brand Name: MEDUSA MULTI-COIL
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): ENDOSHAPE, INC.; 5425 airport blvd.; suite 101; boulder CO 80301
• MDR Report Key: 5405480
• Report Number: 3009688825-2016-00001
• Device Sequence Number: 471534
• Product Code: KRD
• UDI-Device Identifier: 10857798005017
• UDI-Public: (01)10857798005017(17)160731(10)1003804
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Report Date (Section B): 02/01/2016

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: Physician
• Device Expiration Date: 07/31/2016
• Device Model Number: MMC-122
• Device Catalogue Number: 002156
• Device Lot Number: 1003804
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2016
• 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: 52 YR
• Patient Weight: 54