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

Model Number SRD-4-20

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

Patient Problems Intimal Dissection (1333); Vascular Dissection (3160)

Event Date 01/01/2010

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.Since the device was not analyzed, the event could not be confirmed.Vessel injuries and hemorrhages are known inherent risk of mechanical thrombectomy procedure and are documented in the solitaire instruction for use (ifu).Based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure related event.Mdr related to this event: 2029214-2017-00102 2029214-2017-00103 2029214-2017-00104 2029214-2017-00105 2029214-2017-00106 2029214-2017-00107.

Event Description

Medtronic received report through literature review of "outcome of standard and high-risk patients with acute anterior circulation stroke after stent retriever thrombectomy" gratz pp1, jung s, schroth g, gralla j.Stroke.2014 jan;45(1):152-8.Doi: 10.1161/strokeaha.113.002591.Epub 2013 nov 21.Vessel perforation was observed in 2 patients (1, m1 and 1, m2 perforation).Bleeding stopped spontaneously in the patient with the m1 perforation after retraction of the stent retriever, and we were able to stop the bleeding in the patient with the m2 perforation by superselective occlusion of the mca branch with a drop of glue (competitor material).In both patients, follow- up ct on the next day showed no extension of the subarachnoid hemorrhage.There was also report 11 dissections, however, there was no specific allegation of the contributing device.9 patients had clinically symptomatic complications.Most of the symptomatic complications were related to problems in the cervical ica such as iatrogenic dissection (3 of 9).Distal clot embolization was observed in 15 patients.6 embolizations occurred in a previously uninvolved vascular territory.No negative impact was reported for these 21 patients.

• Brand Name: SOLITAIRE RD
• 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 ; 9492753836
• MDR Report Key: 6309870
• MDR Text Key: 66763461
• Report Number: 2029214-2017-00102
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K123378
• 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
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SRD-4-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention