MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CONCERTO PGLA HLX; DEVICE, EMBOLIZATION, VASCULAR

Model Number	PV-12-30-HELIX
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that this coil broke during the procedure.The implant coil remains in the patient.Device or device fragments remain in patient.Resistance felt when the device broke.The patient was undergoing coiling treatment.There were no patient symptoms or complications associated with this event.There were no abnormalities reported in relation to anatomy.No patient injury was reported.The devices were prepared and used per the instructions for use.

• Brand Name: CONCERTO PGLA HLX
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9162215
• Report Number: 2029214-2019-00990
• Device Sequence Number: 2308150
• Product Code: KRD
• UDI-Device Identifier: 00847536016941
• UDI-Public: 00847536016941
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/07/2019

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: 07/15/2021
• Device Model Number: PV-12-30-HELIX
• Device Lot Number: A676085
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2019
• Initial Report FDA Received Date: 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1