MAUDE Adverse Event Report: GARDIA MEDICAL LTD. WIRION; WIRION EPD

Model Number	P2-9-0705-S
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Transient Ischemic Attack (2109)
Date of Event	07/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
A carotid procedure was conducted on a (b)(6) year old male.The filter was successfully placed in the internal carotid artery with no issues.The carotid procedure was completed with no events.Once trying to retrieve the filter, it would not collapse.No visible obstruction or tortuous anatomy was observed.The physician applied high force in order to retrieve the filter.Eventually it was retrieved and it was noted that the tip of the filter was missing and it was located lodged in the distal ica.The tip was captured and retrieved successfully.

• Brand Name: WIRION
• Common Device Name: WIRION EPD
• Manufacturer (Section D): GARDIA MEDICAL LTD.; 2 ha-eshel street; caesarea, 30889 00; IS 3088900
• MDR Report Key: 7804299
• Report Number: 3012121095-2018-00001
• Device Sequence Number: 13790859
• Product Code: NTE
• UDI-Device Identifier: 07290015512015
• UDI-Public: (01)07290015512015(17)191212(10)DS17003
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K143570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/12/2019
• Device Model Number: P2-9-0705-S
• Device Catalogue Number: P2-9-0705-S
• Device Lot Number: DS17003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 08/22/2018
• 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: 55 YR