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

Model Number	MMC-122
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Embolization device was not explanted.Delivery system was returned for evaluation.No device defect found in returned delivery system.Detach slide found in position partway through detach travel.User reported initial partial deployment beyond the maximum distance before retraction recommended in the ifu.
Event or Problem Description
The device did not form the expected coil pack when first partially deployed in an estimated 15.8 mm venous aneurysm.The device was partially deployed farther than is recommended before retraction.The physician retracted the device, repositioned, and deployed again.During this second attempt, the device became completely detached, presenting an embolism risk.The physician held the device in place and placed three sutures to immobilize the device.The patient did not suffer any adverse effects.
Additional Manufacturer Narrative
Embolization devices from same lot evaluated.No defect found in evaluated devices.

• 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: 6440218
• Report Number: 3009688825-2017-00001
• Device Sequence Number: 10970268
• Product Code: KRD
• UDI-Device Identifier: 10857798005017
• UDI-Public: (01)10857798005017(17)170430(10)1004356
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K140796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 04/30/2017
• Device Model Number: MMC-122
• Device Catalogue Number: 002156
• Device Lot Number: 1004356
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/20/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/02/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2017
• Supplement Report FDA Received Date: 04/19/2017
• 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: 47 YR
• Patient Weight: 70