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

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

Patient Problems Intimal Dissection (1333); Infarction, Cerebral (1771); Intracranial Hemorrhage (1891); Neurological Deficit/Dysfunction (1982); Visual Impairment (2138); Thromboembolism (2654)

Event Date 05/04/2013

Event Type  Injury  

Manufacturer Narrative

Mourand, i.Et al.(2014).Mechanical thrombectomy with the solitaire device in acute baislar artery occlusion.Journal of neurointerventional surgery, 4, 200-204.Http://dx.Doi.Org/10.1136/neurintsurg-2012-010629 the solitaire fr devices have not been returned for evaluation; product analysis cannot be performed.Based on the reported information, there does not appear to have been any defect of the devices during use.The events occurred in the patients post-procedure and its causes could not be conclusively determined from the provided information.Mdrs related to this article: 2029214-2017-01204, 2029214-2017-01205.

Event Description

Medtronic literature review found reports of patient complications after solitaire fr mechanical thrombectomy.The purpose of this article was to evaluate the efficacy and safety of mechanical thrombectomy with the solitaire fr in revascularization of patients with acute basilar artery occlusion and to identify the predictive factors for clinical outcome.The authors reviewed 31 patients with acute ischemic stroke attributable to abao treated with the solitaire device within 24 hours of symptom onset.The patients¿ mean age was 61 years; 15 patients were male.The article states the following complications occurred: - seven patients experienced embolic infarcts in a new territory without death.The embolic infarcts were observed in dwi.Of the seven patients, four patients had a poor outcome (mrs > 2).- one patient developed post-procedural vertebral dissection with infarction of the posterior inferior cerebellar artery - four cases of symptomatic intracranial hemorrhage related to the acute therapy occurred within the first 31 hours.Of the four patients, all four had a poor outcome (mrs > 2).

• Brand Name: SOLITAIRE FR
• 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: 6992342
• MDR Text Key: 90738939
• Report Number: 2029214-2017-01204
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K113455
• 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: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2017
• 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