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

Device Problem Occlusion Within Device (1423)

Patient Problem Stenosis (2263)

Event Date 10/20/2017

Event Type  Injury  

Manufacturer Narrative

Average age, majority gender,event date is literature article published online date   recurrent stenosis following carotid artery stenting treated with a drug-eluting balloon: a single-center retrospective analysis c.Pohlmann & j.Höltje & m.Zeile & f.Bonk & p.P.Urban & r.Brüning neuroradiology (2018) 60:81¿87 doi.Org/10.1007/s00234-017-1935-7.If information is provided in the future, a supplemental report will be issued.

Event Description

The journal documents a retrospective single center analysis of patients with carotid artery stenting between 2009 and 2015.Nine patients with high-grade carotid artery in stent restenosis were identified.In the original index procedures, all patients had carotid artery stenting carried out.A protege carotid stent was used in one patient while non-mdt devices were used in the other eight patients.Restenosis occurred in all patients post procedure.All nine patients were then retreated using drug eluting balloons.Medtronic in.Pact amphiprion balloons were used in five of these procedures.Restenosis occurred in one patient during the follow up period post deb treatment.There were no product problems and no other adverse events reported in cases where a medtronic device was used.Two deaths occurred during the follow up period: one deceased due to a bronchial carcinoma and the other deceased due to urosepsis.Both deaths were unrelated to the deb treatment.

• 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: 7365922
• MDR Text Key: 103323143
• Report Number: 2183870-2018-00150
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• 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: 02/15/2018
• 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: 66 YR