MAUDE Adverse Event Report: COVIDIEN (IRVINE) SOLITAIRE FR 3 - SOLITAIRE PLATINUM REVASCULARIZATION DEVICE; CATHETER, THROMBUS RETRIEVER

Model Number	SFR3-4-40-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Death (1802); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/10/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
The solitaire device was not returned as it remains in the patient.The ancillary devices were discarded.As a result, the cause of the reported detachment cannot be determined.Additional information has been requested.Should it become available, a supplemental report will be submitted.
Event or Problem Description
Medtronic received information that the solitaire detached in the patient and was left in the m1/a1.There was no access to the device to make a retrieval attempt.The procedure was not completed and the vessel was not revascularized.The solitaire mechanical thrombectomy procedure was performed to treat the left mca.The vessel tortuosity was extremely tortuous.The device was examined prior to use and no damage was observed.There was no resistance during advancement, however there was significant resistance during retrieval and the solitaire detached at the proximal end; the entire stent portion was left in the patient.The device was torqued during the procedure.The nihss pre and post procedure is not available as the patient has expired.
Additional Manufacturer Narrative
Unique identifier (udi) #: correction.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Adverse event or product: correction.Outcome attributed to adverse event: correction.Type of reportable event: correction.Patient code: correction.Information is provided in the future, a supplemental report will be issued.

• Brand Name: SOLITAIRE FR 3 - SOLITAIRE PLATINUM REVASCULARIZATION DEVICE
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 6407346
• Report Number: 2029214-2017-00187
• Device Sequence Number: 13460021
• Product Code: NRY
• UDI-Device Identifier: 00847536020535
• UDI-Public: 00847536020535
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K153071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2017

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: 12/22/2018
• Device Model Number: SFR3-4-40-10
• Device Lot Number: A393969
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2017
• Supplement Date Received by Manufacturer: Not provided; 04/04/2017
• Initial Report FDA Received Date: 03/15/2017
• Supplement Report FDA Received Date: 04/04/2017; 10/10/2017
• 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: Death; Other