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

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

Patient Problems Aneurysm (1708); Stroke/CVA (1770); Hematoma (1884); Hemorrhage/Bleeding (1888); Transient Ischemic Attack (2109)

Event Date 03/01/1999

Event Type  Injury  

Manufacturer Narrative

(b)(4).Age at event: average age.Pt gender: gender majority.Date of event: estimate from content of article literature: mendiz, o.A., et al.(2016)."transradial versus transfemoral carotid artery stenting: a 16-year single-center experien ce." journal of interventional cardiology 29(6): 588-593 doi: 10.1111/joic.12342.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A study was performed to investigate transradial versus transfemoral carotid artery stenting.Study ranged from march 1999 to march 2015 and included 775 patients.In tr group average patient age was 71 years and 79.2% were male.In tf group average patient age was 69.7 years and 70.9% were male.The following medtronic devices were used in the study; spider, protege, cristallo ideale, moma <(>&<)> percusurge.Stent deployment technique did not differ from the one used with tf-cas.Distal protection was used in all tr cases and in most tf (some cases were done with proximal protection).Patients were examined post-procedure during their hospital stay.Stroke was reported for 20 patients.Approx 1 of them occurred in the contralateral territory in the context of new-onset atrial fibrillation.This stroke was judged to be cardioembolic in nature.Approx 11 cases of tia were reported.Four patients had major bleeding, 1 of them requiring vascular surgery due to retroperitoneal aneurysm.Two other patients had superficial femoral aneurysm, 1 of them requiring thrombin injection.Approx 1 patient had a forearm hematoma that was treated medically.Approx 7 patient deaths occurred during post-operative hospital stay, all in the context of combined coronary artery bypass grafting and percutaneous carotid intervention mainly related to complications of cardiac surgery.Approx 3 further patient deaths were reported during 30 day follow-up.The investigator assessed that none of reported events in this publication were attributed to medtronic devices.All of them were procedural or post procedural complications related with the procedure and/or additional procedures such as cardiac surgery in an extremely high risk population.

Manufacturer Narrative

Relevant history: the study population had a prior medical history of diabetes mellitus (%) 21 (20.8) 158 (23.4) 0.55, smoker (%) 44 (43.5) 281(41.7) 0.72, coronary artery disease (%) 20 (19.8) 189 (28) 0.082, chronic renal failure (%) 4 (4) 21 (3.1) 0.65, atrial fibrillation (%) 4 (4) 21 (3.1) 0.65, prior carotid revascularization (%) 3 (3) 38 (5.6) 0.26, prior neurological event (%) 29 (28.79) 233 (34.5) 0.24.If information is provided in the future, a supplemental report will be issued.

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; 4600n nathan lane; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600n nathan lane; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6383330
• MDR Text Key: 69205344
• Report Number: 2183870-2017-00107
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• 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: 02/06/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 70 YR