FDA Adverse Event Injury Summary report: N

SOLITAIRE FR2

MDR report key: 5340460 · Received January 4, 2016

Report

Report Number: 2029214-2016-00001
Event Type: Injury
Date Received: January 4, 2016
Date of Event: December 6, 2015
Report Date: December 11, 2015
Manufacturer: COVIDIEN (IRVINE)
Product Code: NRY
PMA / PMN Number: K141491
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4) THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THEREFORE, OUR INVESTIGATION WAS LIMITED AND THE UNDERLYING ROOT CAUSE COULD NOT BE DETERMINED. THERE IS NO ALLEGATION OR EVIDENCE THAT THE DEVICE DID NOT FUNCTION AS INTENDED. VASOSPASM IS A KNOWN INHERENT RISK OF MECHANICAL THROMBECTOMY PROCEDURE AND IS DOCUMENTED IN THE SOLITAIRE2 REVASCULARIZATION DEVICE INSTRUCTION FOR USE. BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE DEVICE WAS DEFECTIVE, BUT RATHER A PROCEDURE RELATED EVENT.

Description of Event or Problem · 1

MEDTRONIC RECEIVED INFORMATION THROUGH CLINICAL DATA THAT A PATIENT EXPERIENCED VASOSPASM DURING A MECHANICAL THROMBECTOMY PROCEDURE. THE PATIENT WAS TREATED FOR A LEFT MIDDLE CEREBRAL ARTERY (MCA) OCCLUSION. IT WAS REPORTED THAT AFTER THE SECOND PASS PERFORMED WITHIN THE M2 OF THE MCA, THE FOLLOW UP ANGIOGRAM REVEALED REVASCULARIZATION WITH THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 2B. HOWEVER, PROFOUND VASOSPASM WAS NOTICE IN THE BRANCHES OF THE MCA. THIS WAS TREATED WITH INFUSION OF 3 MG OF INTRA-ARTERIAL MILRINONA AND 5 MG OF INTRA-ARTERIAL NICARDIPINE. THE VASOSPASM HAS SIGNIFICANTLY IMPROVED AFTER THE TREATMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
832	SOLITAIRE FR2	CATHETER, THROMBUS RETRIEVER	NRY	COVIDIEN (IRVINE)	SFR2-4-40	A153820

Patients

Seq	Age	Sex	Outcome	Treatment
1	00052 YR		Required Intervention	INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA)