MAUDE Adverse Event Report: COVIDIEN PROTEGE RX CAROTID STENT SYSTEM; STENT, CAROTID

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

Patient Problems Bradycardia (1751); Stroke/CVA (1770); Low Blood Pressure/ Hypotension (1914)

Event Date 06/24/2021

Event Type  Injury  

Manufacturer Narrative

Title: incidence and predictors of prolonged hemodynamic depression after carotid artery stenting: yet another benefit of statins? author: ayhan erkol, yalçin dalgiç, serhan yildirim journal: clinical neurology and neurosurgery year: 2021 vol/issue: 207 ref: doi: 10.1016/j.Clineuro.2021.106786.Age or date of birth: average age, sex: majority gender, date of event: date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a retrospective study to assess the incidence and predictors of prolonged hemodynamic depression (phd) after carotid artery stenting (cas).207 patients were included in the study, who underwent 216 cas procedures.Of the devise used during procedures, medtronic¿s spider fx embolic protection device and protégé rx carotid stents were used.70% of procedures were performed in symptomatic patients.The neurological event was transient ischemic attack in 53%, and stroke in 47% of the symptomatic cases.All of the procedures were successfully completed with stenting.Distal filters were used in 152 (70.4%) cas procedures.Phd developed after 56 (25.9%) cas procedures.Of the 56 cases with phd, inotropic support was required in 9 (16%) cases to maintain sbp over 90 mmhg.The overall periprocedural stroke rate was % 2.8.Among patients with no phd, 4 (2.5%) procedures were complicated by minor strokes and 1 (0.6%) patient had a major stroke.One procedure in the phd group was complicated by minor stroke in the first week after discharge.The protege stent was more frequently used in the procedures followed by phd, compared to the phd-free procedures (50% vs % 20).Protege stent was found to be significantly associated with phd.When compared with a non-medtronic stent, the odds of phd was 3.8 fold greater, when the protege stent was used.There was a weak association between distal filter usage and phd at univariate analysis.The author concludes patients with asymptomatic lesions and stenosis close to the bifurcation are more prone to phd.The type of the stent implanted significantly influences the risk of phd.

• Brand Name: PROTEGE RX CAROTID STENT SYSTEM
• Type of Device: STENT, CAROTID
• 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: 12768435
• MDR Text Key: 280457519
• Report Number: 2183870-2021-00405
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P060001
• 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: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• 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: 11/02/2021
• 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): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male