MAUDE Adverse Event Report: COVIDIEN (IRVINE) SOLITAIRE FR2; CATHETER, THROMBUS RETRIEVER

Model Number SFR2-4-40

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

Patient Problems Intimal Dissection (1333); Ischemia (1942); Vasoconstriction (2126); Therapeutic Response, Decreased (2271)

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

Zibold, f., mordasini, p., mosimann, p., piechowiak, e., dobrocky, t., fischer, u.,.Gralla, j.(2017).Safety of the solitaire 4 × 40 mm stent retriever in the treatment of ischemic stroke.Cardiovascular and interventional radiology.Doi:10.1007/s00270-017-1785-z the solitaire fr 2 devices have not been returned for evaluation; product analysis cannot be performed.Based on the provided information, there does not appear to have been any defect of the devices during use.The causes of the events could not be conclusively determined from the provided information.Mdrs related to this article: 2029214-2017-01088 2029214-2017-01089.

Event Description

Medtronic received report of infarct and vasospasm during or after solitaire 2 fr mechanical thrombectomy.The purpose of this article was to evaluate the safety and efficacy of the solitaire 2 fr 4x40 for large vessel occlusion in stroke patients.The authors retrospectively reviewed 23 patients with occlusions in the anterior or posterior cerebral circulation.The article did not provide patient demographic information.The article states that tici 2b or better recanalization was achieved in 22 patients.In one patient (patient 19), the intervention was terminated after one unsuccessful thrombectomy due to an already visible large infarct volume.In addition, the patient¿s follow-up imaging showed contrast extravasation.The article states that one patient (patient 6) experienced intraprocedural vasospasm.The patient presented with an m1 occlusion an d underwent one pass of the solitaire device resulting in tici 3 reperfusion.Significant vasospasm after thrombectomy was observed in the proximal m1 segment.The vasospasm was fully reversed with local intra-arterial infusion of 2mg nimodipine.

Manufacturer Narrative

Event description - additional information.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received additional information from the corresponding author: of the 23 patients evaluated for this article, 10 were female and 13 were male.The mean age was 38.12 years.The patients' weights are not available.In addition, the author reported that none of the adverse events were directly related to any medtronic device.

• Brand Name: SOLITAIRE FR2
• 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: 6906342
• MDR Text Key: 87846777
• Report Number: 2029214-2017-01088
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K141491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SFR2-4-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2017
• 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): Other; Required Intervention