MAUDE Adverse Event Report: COVIDIEN SPIDER RX; CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE

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

Patient Problems Bradycardia (1751); Ischemia (1942); Myocardial Infarction (1969); Transient Ischemic Attack (2109)

Event Date 04/11/2019

Event Type  Injury  

Manufacturer Narrative

Age/date of birth; average age.Sex; majority gender.Date of event: date of publication journal article title: postoperative ischemic events in patients undergoing carotid artery stenting using algorithmic selection for embolic protection the neuroradiology journal 2019, vol.32(4) 294¿302! the author(s) 2019 article reuse guidelines: sagepub.Com/journals-permissions doi: 10.1177/1971400919839644 journals.Sagepub.Com/home/neu.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.

Event Description

Purpose: carotid artery stenting (cas) is a valuable alternative to carotid endarterectomy, especially in high-risk patients.However, the reported incidences of perioperative stroke and death remain higher than for carotid endarterectomy, even when using embolic protection devices (epds) during cas.Our purpose was to evaluate 30-day major adverse events after cas when selecting the most appropriate epd.Event description: protégé, spider rx and moma distal embolic protection device were used in carotid artery stenting procedures.The lesions were pre dilated and post dilated in most cases using a non-medtronic device.The patients have a history of hypertension, hyperlipidemia, diabetes mellitus, current smoker, coronary artery disease, peripheral artery disease, chronic kidney disease, previous cea, previous cas.Technical success was achieved in all lesions.Perioperative adverse events including amaurosis fugax, minor stroke, myocardial infarction, transient ischemic attack, perioperative hypotension, perioperative bradycardia, sustained hypotension, puncture site hematoma and acute exacerbation of chronic kidney dysfunction occurred, stenosis treated with stenting.Methods: we reviewed the clinical outcomes of 61 patients with 64 lesions who underwent cas with epds.Patients who underwent cas associated with thrombectomy and who had a preoperative modified rankin scale score >3 were excluded from the analysis.The epd was selected based on symptoms, carotid wall magnetic resonance imaging and lesion length, and we analyzed combined 30-day complication rates (transient ischemic attack, minor stroke, major stroke or death).Results: forty-nine patients were men and 12 were women.The median age was 72 years (range: 59¿89 years) and 44 lesions were asymptomatic.A filter-type epd was selected in 23 procedures, distal-balloon protection in 14 procedures and proximal-occlusive protection in 27 procedures.Two patients (3.1%) experienced a transient ischemic attack and one patient (1.6%) had a minor stroke within 30 days of the procedure.No patients experienced procedure-related morbidities (modified rankin score >2) or death.Conclusions: the perioperative stoke rate was low when we selected a proximal-occlusive-type epd in high-risk patients with vulnerable carotid artery disease.Our algorithm for epd selection was an effective tool in the perioperative management of carotid artery stenosis.

• Brand Name: SPIDER RX
• Type of Device: CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION 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: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8929640
• MDR Text Key: 159518640
• Report Number: 2183870-2019-00413
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• 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: 08/02/2019
• 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: 72 YR