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

Device Problem Material Deformation (2976)

Patient Problems Infarction, Cerebral (1771); Paresis (1998); Patient Problem/Medical Problem (2688)

Event Date 11/09/2018

Event Type  Injury  

Manufacturer Narrative

Event date: date of article publication surgical rescue retrieval of a filter protection device in carotid artery stenting with stent deformation: case report and literature review world neurosurgery volume 122, february 2019, pages 215-219 10.1016/j.Wneu.2018.10.214.If information is provided in the future, a supplemental report will be issued.

Event Description

Background: despite the development of neuroendovascular treatment, device-related complications requiring surgical procedures remain.We report a case requiring surgical retrieval of a filter protection device in carotid artery stenting (cas) with an open-cell stent, due to stent deformation, and review past reports on cas in which surgical retrieval of devices was required.¿ case description: an (b)(6) man underwent cas for symptomatic right internal carotid artery stenosis with severe calcification and tortuosity.Immediately after placement of the protégé 10x60mm carotid artery stent, stent deformation was detected and the filter protection device could not be retrieved.All noninvasive device retrieval attempts failed, including the use of a snare device, and the filter protection device was ultimately retrieved surgically.The protégé carotid artery stent remains in situ as there was no flow issue on the intraoperative angiogram.After surgery, right cerebral infarction progressed slightly (including left upper limb paresis, hoarseness and swallowing disorder) but no permanent deficit was observed.Dual antiplatelet therapy was continued and no adverse effect was observed 4 months after treatment.

• Brand Name: PROTEGE RX CAROTID STENT SYSTEM
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): COVIDEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8212831
• MDR Text Key: 131946448
• Report Number: 2183870-2019-00003
• 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
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2018
• 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: 82 YR