MAUDE Adverse Event Report: COVIDIEN (IRVINE) SOLITAIRE FR3; CATHETER, THROMBUS RETRIEVER

Model Number	SFR3-4-20-05
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was 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.Hemorrhages are known inherent risk of endovascular procedure and are documented in our device¿s instruction for use (ifu).Based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure and patient condition related event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that the bleeding was confirmed under angiography after retrieving the solitaire stent from the occlusion site (m2).The physician immediately embolized the bleeding site with 3 ed coils.The thrombus was recovered and the procedure was finished.The physician noted that the solitaire device did not malfunction and that the doctor made the wrong choice in device selection from the viewpoint of the blood vessel tortuosity as well as the elderly patient.

• Brand Name: SOLITAIRE FR3
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 8410000
• Report Number: 2029214-2019-00186
• Device Sequence Number: 10841150
• Product Code: NRY
• UDI-Device Identifier: 00847536027053
• UDI-Public: 00847536027053
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/04/2020
• Device Model Number: SFR3-4-20-05
• Device Lot Number: A750057
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2019
• 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