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); Thromboembolism (2654)

Event Date 05/24/2016

Event Type  Injury  

Manufacturer Narrative

Mean age block, mean gender study title: complications and predictors of hypotension requiring vasopressor after carotid artery stenting masataka nanto, yudai goto, hiroyuki yamamoto, seisuke tanigawa, hayato takeuchi, yoshikazu nakahara, hiroshi tenjin, and michiko takado doi: 10.2176/nmc.Oa.2016-0155.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

The study retrospectively analyzed the medical records of (b)(4) cases who underwent cas for symptomatic and asymptomatic carotid artery stenosis.Among them, four cases who suffered progressive stroke and were treated in the acute phase were excluded from this study.Finally (b)(4) cases were included in this retrospective study.Patients were treated with closed cell stents and open cell stents including protégé stents.It is reported that 30-day stroke occurred in six cases.New ischemic lesions detected on postprocedural dw-mri were observed in (b)(4) cases of the hg group and (b)(4) cases of the nhg.It is reported that patient death occurred.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 ; 091708734
• MDR Report Key: 6543318
• MDR Text Key: 74357387
• Report Number: 2183870-2017-00197
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P060001
• 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,Followup
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• 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: 04/05/2017
• 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: 74 YR