MAUDE Adverse Event Report: COVIDIEN SPIDER FX; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

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

Patient Problems Intracranial Hemorrhage (1891); Vascular Dissection (3160); Insufficient Information (4580)

Event Date 07/31/2021

Event Type  Injury  

Manufacturer Narrative

Title: comparison of drug-coated balloons to bare metal stents in the treatment of symptomatic vertebral artery-origin stenosis: a prospective randomized trial author: ming-yi wang, feng wang, yong-sheng liu journal: world neurosurgery year: 2021 vol/issue: 154 ref: doi.Org/10.1016/j.Wneu.2021.07.113.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a prospective randomized trial to compare the technical feasibility and outcomes of drug-coated balloon (dcb) with distal embolic protection devices (epds) compared with bare metal stent (bms) without an epd in patients with symptomatic atherosclerotic vertebral artery-origin stenosis (vaos).Clinical symptoms included vertigo, hemiparesis, dysarthria, diplopia, ataxia.95 patients with symptomatic vaos randomly assigned to treatment with dcb + epd (49 patient¿s) or bms without epd (46 patient¿s) were included in the study.For the population the submarine rapido balloon was used for pre-dilation.Within the epd group medtronic¿s spider fx epd was used.Technical success was completion of the procedure with 30% residual stenosis of the target lesion, without flow-limiting dissection and absence of adverse events within 1 month of the index procedure.Clinical success included technical success and absence of recurrent events at 12 months.Technical success, clinical success, and signal intensity abnormalities on diffusion-weighted imaging within 3 days after operation were compared.The primary endpoint was restenosis (50%) on follow-up cta imaging.Secondary endpoints include technical and clinical success, com plications, and dwi abnormalities (asymptomatic distal embolization) between the dcb + epd and bms without epd groups after procedure.The 30-day technical success rate was 93.9% for dcb group versus 95.7% for the bms group.In the dcb and epd group, 2 patients received bailout stenting due to 1 flow-limiting dissection and 1 residual stenosis >30% after dilation.In the bms without epd group, 1 patient had residual stenosis >30%, which was expanded by a bigger drug-uncoated balloon.The incidence of perioperative complications was 2.1%, with 1 case in the dcb + epd group and the other case in the bms without epd group.A patient in the dcb + epd group had a sudden headache accompanied by left limb weakness 12 hours after surgery.Head computed tomography showed cerebral hemorrhage in the right basal ganglia.The patient received stop antiplatelet aggregation, antihypertensive medications, and other treatments.Symptoms improved and was completely relieved 3 weeks after discharge.One case in the bms group developed dizziness and dysarthria after surgery, and head magnetic resonance dwi showed acute pontine and left cerebellar region infarction.Clinical symptoms were significantly relieved after medication.Within 3 days after surgery, dwi disclosed asymptomatic embolization in 2 patients in the dcb + epd group and 9 patients in the bms without epd group.There were no deaths, major strokes, or myocardial infarctions within 16 months after procedures in either group.At a mean 16-month follow-up, the clinical success rate was 89.8% for the dcb group versus 91.3% for the bms group.

• Brand Name: SPIDER FX
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13721874
• MDR Text Key: 286944930
• Report Number: 2183870-2022-00079
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K111010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• 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: 03/03/2022
• 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
• Patient Age: 67 YR
• Patient Sex: Male