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

Model Number	MMC-122
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Reporting physician is dr (b)(6), assistant professor of medicine, pulmonary hypertension program, division of pulmonary, critical care, and sleep medicine, university of (b)(6).Address: (b)(6), phone: (b)(6), email: (b)(6).The device is alleged to have migrated from the left internal iliac vein to the pulmonary artery more than two years after implantation.Time of migration occurrence is estimated based on onset of pt symptoms, and physician reported the pt had imaging approx one year prior which showed the device in the original implanted location.Reporting physician did not know the dr or institute for original implantation, and did not have images of implanted device.Pt was reported as stable and being evaluated for surgical removal of the device from the pulmonary artery.New info was presented to mfr in april 2019 by legal rep of pt, indicating pt was initially treated by primary care physician in (b)(6) 2018 for congestion, cough, and shortness of breath.Ct scan performed in (b)(6) 2018 indicated "coil-like metallic structure in the right basilar lobe pulmonary arteries." an attempt to remove the device was performed at (b)(6) hospital on (b)(6) in (b)(6) 2018 without success.Pt was referred to division of thoracic and cardiovascular at the (b)(6) hosp.Ultimately the device was removed by dr (b)(6) at (b)(6) hosp in (b)(6) 2018.Legal rep of pt claims to have possession of the device.To date, the mfr has not been provided the device or any imaging for review.Identity of the device has not been confirmed by the mfr.Fda safety report id# (b)(4).

• Brand Name: MEDUSA MULTI-COIL
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): ENDOSHAPE INC. ; boulder CO 80301
• MDR Report Key: 8662451
• Report Number: MW5087079
• Device Sequence Number: 1967966
• Product Code: HCG
• UDI-Device Identifier: 10857798005017
• UDI-Public: 10857798005017
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Voluntary
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2019

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?: No
• Operator of Device: No Information
• Device Model Number: MMC-122
• Device Catalogue Number: MMC-122
• Device Lot Number: T978
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/31/2019
• 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: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 112