MAUDE Adverse Event Report: MEDTRONIC NEUROVASCULAR CONCERTO PGLA HLX; DEVICE, EMBOLIZATION, VASCULAR

Model Number	PV-12-40-HELIX
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that coil migration after 3 months coiling procedure.It was reported that patient was treated with concerto coil for a gonadal embolization.3 months after, the patient went to the hospital with respiratory distress; the x-ray showed a coil device inside the left lung.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that coil migration after 3 months coiling procedure, for left and right gonadal vein, and both hippo gastric veins.The x-ray showed the whole coil.2 additional coils were used to treat the patient.The patient has not received additional treatment for the respiration issue or the pelvic congestion ovarian issue.The patient is not on antiplatelet medication.The patient has a total of 4 coils implanted.The coils were confirmed to have been implanted in the correct location.The coils will not be removed from their current location.The patient is in good condition and does have concerns for the coils that are in her lung.

• Brand Name: CONCERTO PGLA HLX
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MEDTRONIC NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8142912
• Report Number: 2029214-2018-01036
• Device Sequence Number: 10817243
• Product Code: KRD
• UDI-Device Identifier: 00847536016972
• UDI-Public: 00847536016972
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2019

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: Health Professional
• Device Expiration Date: 09/13/2020
• Device Model Number: PV-12-40-HELIX
• Device Catalogue Number: PV-12-40-HELIX
• Device Lot Number: A523488
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 12/09/2018
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 01/03/2019
• 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: Other
• Patient Age: 62 YR