MAUDE Adverse Event Report: COVIDIEN (IRVINE) CONCERTO PGLA HLX; DEVICE, EMBOLIZATION, VASCULAR

Model Number	PV-18-40-HELIX
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was reported to have been discarded at the site.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 the implant coil prematurely detached and was removed from the patient.The pushwire was not bent or broken and was discarded.The physician did not reposition the coil and did not attempt to detach it.The pushwire was not rotated and there was mention of migration after deployment.The coil was removed with a snare device.No patient injury was reported as a result of the event.The patient's vasculature was severe in tortuosity and the patient's blood flow was normal.

• Brand Name: CONCERTO PGLA HLX
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 8409297
• Report Number: 2029214-2019-00182
• Device Sequence Number: 420293
• 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
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/11/2019

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: 02/09/2021
• Device Model Number: PV-18-40-HELIX
• Device Lot Number: A595851
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 03/11/2019
• 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 Weight: 59