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

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Infarction, Cerebral (1771); Hemorrhage/Bleeding (1888); Hemorrhage, Cerebral (1889); Thrombosis (2100); Thrombus (2101)

Event Date 02/16/2018

Event Type  Injury  

Manufacturer Narrative

Age at event: mean age.Sex: majority sex.Date of event: estimate based on date of publication.Acta neurochirurgica (2018) 160:1121¿1127 https://doi.Org/10.1007/s00701-018-3487-y.If information is provided in the future, a supplemental report will be issued.

Event Description

One-hundred forty-three (143) patients with an average age of 72, underwent common and external carotid stenting.A moma ultra proximal protection device, spider fx, protégé rx, percusurge guidewire and non-medtronic devices.It is reported one patient had major cerebral infarction that occurred 3 days after cas due to stent thrombosis, a second patient suffered cerebral haemorrhage 3 weeks after the procedure due to hyperperfusion syndrome.

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: 7685129
• MDR Text Key: 113886447
• Report Number: 2183870-2018-00379
• 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,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• 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: 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): Required Intervention
• Patient Age: 72 YR