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 Arrhythmia (1721); Stroke/CVA (1770); Hematoma (1884); Myocardial Infarction (1969); Transient Ischemic Attack (2109); Vascular Dissection (3160); Thrombosis/Thrombus (4440); Cramp(s) /Muscle Spasm(s) (4521); Restenosis (4576)

Event Date 04/25/2022

Event Type  Injury  

Event Description

Medtronic received a journal article reporting on 'carotid restenosis rate after stenting for primary lesions versus restenosis after endarterectomy with creation of risk index'.A total of 782 patients were divided into 2 groups: the cas (prim) group consisted of 440 patients in whom cas was performed for primary lesions, and the cas (res) group consisted of 342 patients with cas due to restenosis after cea.Indications for cas were symptomatic stenosis/restenosis >70% and asymptomatic stenosis/restenosis >85%.A color duplex scan (cds) of carotid arteries was performed 6 months after cas, after 1 year, and annually afterward.Follow-up ranged from 12 to 88 months, with a mean follow-up of 34.6±18.0 months.An artery was punctured after administration of local anesthesia followed by a short 6 french (fr) sheath introduction over a 0.035 wire, with the wire advanced into the aortic arch.Target artery cannulation was performed using judkins right (terumo, japan) 5 fr or simmons sidewinder (merit medical, usa) 5 fr diagnostic catheters.After stabilization of the wire in the external carotid artery, a 7- or 8-fr guiding sheath was introduced (destination [terumo, japan], sheathless [asahi intecc, japan], brite tip [cordis, usa]) followed by positioning of a distal embolic protection device (epd) over the guidewire (spider fx [medtronic, usa], angioguard [cordis, usa], filterwire [boston scientific, usa], emboshield [abbott, usa]).Pre-dilation was performed in cases of tight stenosis with noncompliant coronary balloons, depending on the operator¿s decision.Cas was then performed (protégé [medtronic, usa], wallstent [boston scientific, usa], x.Act [abbott, usa], roadsaver [terumo, japan]) with mostly closed-cell design stents, whereas open-cell design stents were used in case of associated angulations.Post-dilation also depended on operators¿ decisions and was mostly performed with dedicated 5 to 6 mm carotid balloons (aviator [cordis, usa], sterling [boston scientific, usa]).At the end of the procedure, the puncture site was closed either manually or by placing an angio-seal (terumo, japan) or femoseal (terumo, japan) closure device.Technical success was defined as residual stenosis <(><<)>20%.Following this procedure, patients were administrated dual antiplatelet therapy and statins for at least 6 months followed by aspirin and statins only or continued with clopidogrel if significant early cr was seen on the control cds findings.Cds of carotid arteries was performed after 6 months, 1 year, and annually afterward.Postcas cr was defined as any new intraluminal reduction >50% caused by intimal hyperplasia or novel atherosclerotic lesions, whereas significant cr was defined as a reduction >70% regardless of symptom presence or need for ¿redo¿ intervention.Mdct arteriography was performed to assess repeated endovascular interventions in symptomatic patients with post-cas cr >70% and asymptomatic patients with cr >85%.The study¿s primary endpoint was to analyze the cr rate after cas during the follow-up and evaluate all cr development predictive factors.Secondary endpoints were early and long-term results of the 2 groups, including access site complications (hematoma, dissection, flap, and arterial thrombosis); neurological complications, such as tia, stroke, myocardial infarction, pulmonary, and kidney complications; and neurological and overall mortality.Follow-up ranged from 12 to 88 months with a mean follow-up of 34.6±18.0 months.The overall cr rate was 7.9% and there was no difference between the patients in the cas (prim) and cas (res) group (8.7% vs 7.2%).Similarly, there was no difference in terms of cr during the follow-up between symptomatic and asymptomatic patients.The overall significant post-cas cr rate was 5.6%, with no difference between patients in the cas (prim) and cas (res) groups (6.4% vs 4.7%).Mdct angiography confirmed all significant crs diagnosed earlier by cds, except for 12 patients in whom no significant cr was registered.Re-intervention was performed in patients with symptomatic cr or high-grade asymptomatic cr >85%.There were no differences in early and long-term rates of access site complications, tia, stroke, neurological issues, or overall mortality between patients in the cas (prim) and cas (res) groups.Symptomatic significant cr was seen in 4 patients (6.3% of patients with cr); all patients had tia (table 4).Post-cas tias due to significant restenosis occurred after 15, 27, 33, and 41 months.All symptomatic patients were in the cas (prim) group, but this still did not reach statistical significance when compared with cas (res) group (p=0.136).Post-procedural heart arrhythmia was more frequently seen in patients with primary stenosis than patients in the cas (res) group, but there was no difference between the 2 groups when the mi rate was observed.Ica thrombosis occurred in 5 patients: 4 in the cas (prim) group and 1 in the cas (res) group.These subjects had contralateral side weakness and immediately underwent conversion to open surgery and graft interposition.All procedures went uneventful with complete neurological recovery due to prompt reaction and available operating rooms.Periprocedural brain ct showed a minor stroke in 1 patient, but there were no ischemic lesions in others.There was a significant difference in terms of patients requiring additional peripheral percutaneous angioplasty, with more patients in the cas (res) group (7.0% vs 0.9%).

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 15445485
• MDR Text Key: 300130630
• Report Number: 2183870-2022-00303
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• PMA/PMN Number: K111010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2022
• 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: 74 YR
• Patient Sex: Male