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

Model Number SOLITAIRE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Neurological Deficit/Dysfunction (1982); Paresis (1998)

Event Date 08/13/2014

Event Type  Death  

Event Description

Medtronic / covidien received information through literature review of "double solitaire mechanical thrombectomy in acute stroke: effective rescue strategy for refractory artery occlusions?" by author j.Klisch.Out of 10 patients, it was reported that 9 patients had the single solitaire technique applied first with an average of 3 passes (1 ¿ 4 passes).One patient had the procedure started with the double solitaire technique to avoid fragmenting the thrombus due to the length of the thrombus.Five patients were reported to have mrs 2.Three patients were reported to have mrs 4 and two patients were reported to have expired.Complete recanalization (tici 2b/3) was achieved in eight patients.Two deaths were reported.One patient (patient 8) was reported to have expired due to a malignant infarct following failed recanalization of an icat (internal carotid artery) terminus occlusion.The recanalization failed due to a refractory icat stenosis which made vascular access difficult.The other patient (patient 6) had successful recanalization of an icat occlusion with initial neurologic improvement and then secondary deterioration 3 weeks later, with aphasia and hemiparesis due to presumed re-infarction.Subsequently, the patient expired.The information was received from the same article as mdr# 2029214-2015-00525.

Manufacturer Narrative

The report was created to capture the deaths reported in the article that can be found online at: http://dx.Doi.Org/10.3174/ajnr.A4133.The devices involved in the event were not returned for evaluation.No further information were provided regarding the devices.The lot history record reviews were not possible as the lot numbers were not provided.(b)(4).

• Brand Name: SOLITAIRE FR REVASCULARIZATION DEVICE
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 4760219
• MDR Text Key: 5787460
• Report Number: 2029214-2015-00524
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K113455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SOLITAIRE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 70 YR