MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR CONCERTO PGLA HLX; DEVICE, EMBOLIZATION, VASCULAR

Model Number	PV-18-40-HELIX
Medical Device Problem Codes	Separation Failure (2547); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device was used off label.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report the coil was delivered into the gonadal vein but the physician didn't like how it was positioned so they decided to recapture the coil in the sheath, reposition.However, when they tried to release it, the polypropylene yarn was broken and prevented release.It was also noted that the device was jammed/would not close.The devices were prepared as indicated per the ifu.There was no degree of vessel tortuosity.There were no related patient symptoms.

• Brand Name: CONCERTO PGLA HLX
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8111497
• Report Number: 2029214-2018-00985
• Device Sequence Number: 11343967
• Product Code: KRD
• UDI-Device Identifier: 00847536017108
• UDI-Public: 00847536017108
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/28/2018

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: Health Professional
• Device Expiration Date: 02/06/2021
• Device Model Number: PV-18-40-HELIX
• Device Catalogue Number: PV-18-40-HELIX
• Device Lot Number: A593938
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 11/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 67