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 Stroke/CVA (1770); Hematoma (1884); Unspecified Infection (1930); Myocardial Infarction (1969); Unspecified Tissue Injury (4559)

Event Date 07/19/2020

Event Type  Injury  

Manufacturer Narrative

Title: carotid endarterectomy and stenting in a chinese population: safety outcome of the revascularization of extracranial carotid artery stenosis trial author: bin yang, yan ma, tao wang journal: translational stroke research year: 2020 vol/issue: vol.12 issue 12 ref: doi: 10.1007/s12975-020-00835-8.Average age, majority gender, date of publication journal reported death but there is no information to suggest the device caused or contributed to the death events.Deaths are common occurrences in clinical studies, however the cause(s) of death are often not characterized or clearly associated with a particular product.Therefore, deaths will not be considered reportable unless clearly stated as being associated with a medtronic device.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a study which aimed to evaluate the safety outcome profile of carotid endarterectomy (cea) and carotid artery stenting (cas) in chinese patients with carotid artery stenosis.The primary endpoint was any stroke, myocardial infarction and/or death within 1-month post-procedure.For the cas procedure, local anaesthesia and pre-dilation prior to stent placement were recommended.Use of an embolic protection device was mandatory for all patients who underwent cas.Medtronic¿s spider fx embolic protection device was included as an approved device.In addition, medtronic¿s protégé stent and cristallo ideale stent were included as approved stents.The choice of embolic protection devices and stents, dilation strategy, and balloon size was leftto the discretion of the physician.2719 patients were included in the study.A total of 656 patient¿s were in the symptomatic cas group and 887 in the asymptomatic cas group.In the cas symptomatic group, the primary outcome of stroke, mi, or death in patient¿s was reported as 3.8%, and 4.7% in the asymptomatic cas group.Secondary outcomes of stroke, ischaemic stroke, haemorrhagic stroke, mi, and other complications including cranial nerve injury, incision hematoma, and pulmonary infection are reported in both the symptomatic and asymptomatic cas groups.No deaths were reported in the symptomatic cas group.There is no established or suspected causal relationship between the device(s) and the death events.

• 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: 12246287
• MDR Text Key: 264287818
• Report Number: 2183870-2021-00267
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K051379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• 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: 07/12/2021
• 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: 66 YR