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

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

Patient Problems Stroke/CVA (1770); Hematoma (1884); Myocardial Infarction (1969); Obstruction/Occlusion (2422); Pseudoaneurysm (2605); Restenosis (4576)

Event Date 06/29/2020

Event Type  Injury  

Manufacturer Narrative

Journal article title: hemodynamic changes between different anatomically designed stents after carotid stenting: a prospective mult icentre study journal of neurology (2020) 267:3392¿3399 https://doi.Org/10.1007/s00415-020-10032-0.If information is provided in the future, a supplemental report will be issued.

Event Description

The journal article reported 411 patients enrolled into the multi-center study and divided into two stenting groups of straight carotid stenting (scs) and tapered carotid stenting(tcs).Medtronic devices used in both study groups are the spider fx embolic protection device and protege rx self-expanding stent.Patients who underwent the scs and tcs procedures developed bradycardia within 24 h.In both procedures, patients developed hypotension within 24 h.Complications and 12-month outcomes in both procedures reported are one patient developed acute occlusion of the stent in the scs procedure, and this patient developed a disabling stroke and died 3 weeks post procedure.Six and seven patients who underwent the scs and tcs procedures experienced chs, respectively, and recovered within the short-term; these patients received a ct scan that showed no evidence of thromboembolism or new stroke.Four and six pat ients developed post procedure hypertension after the scs and tcs procedures, respectively.Access-site complications were detected in 9 scs patients and 12 tcs patients.Two patients suffered disabling stroke after the scs procedure, 4 patients suffered non-disabling stroke, and 4 patients suffered disabling stroke after the tcs procedure at 12 months.One patient had an mi, and one patient died following the scs procedure.Hematoma and psuedoaneurysm adverse events were also reported.

• Brand Name: SPIDER RX
• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12031214
• MDR Text Key: 257120696
• Report Number: 2183870-2021-00215
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• 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: 05/28/2021
• 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): Hospitalization
• Patient Age: 65 YR
• Patient Weight: 69