MAUDE Adverse Event Report: MEDTRONIC IRELAND EXPONENT® SELF-EXPANDING CAROTID STENT; STENT, CAROTID

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

Patient Problems Stroke/CVA (1770); Transient Ischemic Attack (2109); Stenosis (2263)

Event Date 01/31/2017

Event Type  Injury  

Manufacturer Narrative

Mean age of patient cohort, 81.5% of patient cohort was male event date is literature article published date the effect of increasing operator experience on procedure-related characteristics in patients undergoing carotid artery stenosis vascular : 2017, vol.25(5) 488¿496 literature reference: doi: 10.1177/1708538117691431.

Event Description

The journal article documents a study evaluating the efficacy and safety of carotid artery stenting for the treatment of severe carotid artery disease within a facility.The aim was to analyze all carotid artery stenting (cas) procedures performed within the facility between 2007 and 2015.A total of 207 cas procedures were performed in 200 patients.Both left and right ica lesions were treated.Femoral artery access was obtained using non-mdt guidewires.Cerebral embolic protection devices were used in all cases, followed by stent deployment and post dilation.Stent position typically extended from the common to the internal carotid, crossing the origin of the external carotid artery.Medtronic exponent, cristallo and protégé rx devices were among the brands of stent used.Medtronic interceptor + and moma devices were among the embolic protection devices used.During the study period, there were three technical failures.In one patient the physician was unable to deploy the embolic protection device (epd) proximal to the lesion due to severe ica kinking, while in another patient common carotid artery catheterization was failed due to the presence of hostile aortic arch.The third patient had a nearly occluded ica characterized by an echolucent, irregular plaque and we were not able to cross the lesion.All three patients were converted on site to cea under general anesthesia with a good clinical result.The follow up was scheduled at 1, 6 and 12 months and yearly after procedures.Four patients suffered stroke while 2 patients experienced tia.Cognitive dysfunction that resolved after 3 days was observed in 2 patients.In-stent restenosis was observed in one patient which was treated with a balloon expandable stent shortly after.

Manufacturer Narrative

Correction: outcome attributed to adverse event has been updated to intervention required.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EXPONENT® SELF-EXPANDING CAROTID STENT
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7040011
• MDR Text Key: 92302228
• Report Number: 9612164-2017-01626
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: P070012
• 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: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• 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: 10/18/2017
• 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): Life Threatening; Required Intervention
• Patient Age: 71 YR