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

Catalog Number UNK-PLY-PROCARO

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

Patient Problem Paresis (1998)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

Mean age.Majority gender.Date of event: published date of article online safety and feasibility of carotid artery stenting with dual- echo technique to minimize iodinated contrast dose journal of stroke and cerebrovascular diseases, vol.27, no.4 (april), 2018: pp 825¿830 https://doi.Org/10.1016/j.Jstrokecerebro.If information is provided in the future, a supplemental report will be issued.

Event Description

Event: sixty-three consecutive patients were enrolled in the study and underwent carotid artery stenting; sixty-two patients were treated with the protégé rx.The patients have a history of hyperlipidemia, hypertension, diabetes mellitus, atrial fibrillation, current smoker, ischemic heart disease, symptomatic lesion.Treatment was carried out between september 2009 to july 2013.3 non-medtronic embolic protective devices were used in all cases.A percusurge guardwire was used in some cases, flow-reversal protection using percusurge and a non-medtronic was also performed.The lesion was predilated was performed using the protégé rx and two other non-medtronic devices.After positioning the protective devices, 3 non-medtronic, catheters were advanced over a.014-inch guidewire and placed in the distal ica.Post dilatation was performed with a 4.5- 6.0 × 30-mm balloon.Technical success was achieved in all cases.It was reported post procedure 1 case of transient hemiparesis in the decas group, and 1 transient and 1 permanent case of hemiparesis in the stcas group.

• 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: 7841913
• MDR Text Key: 119061972
• Report Number: 2183870-2018-00431
• 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: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-PLY-PROCARO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• 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): Other
• Patient Age: 71 YR