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

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

Patient Problem Stroke/CVA (1770)

Event Date 11/28/2016

Event Type  Injury  

Manufacturer Narrative

Age: mean age (range 53-83 years).Gender: mean gender (21 males, 8 females) study title: carotid artery stenting in high-risk patients: a single-center experience.Mohamed k.Elewa.Doi: 10.4103/1110-1083.202380.

Event Description

A retrospective review of patients who were candidate for carotid artery stenting (cas) procedures was performed.Clinical presentation included amaurosis fugax, transient ischemic attack, minor stroke, major stroke.All cases were performed via the femoral approach.A guide catheter or long sheath was advanced to the common carotid artery (cca).The culprit lesion was visualized in at least two different projections before and after the procedure.The intracranial circulation was visualized in all patients before and after the procedure.In all patients, a spiderfx embolic protection system, embolic protection devices (epd) was used.All lesions were treated with self-expandable nitinol stents.The stents were 30¿40mm in length, and the stent diameter ranged from 6 to 10mm (either tapered or straight).Protégé rx carotid stents were used during procedures.In tight, subocclusive carotid stenosis, predilation was done using low-profile (2¿3mm in diameter) 0.014-inch wire compatible balloons.After stent placement, postdilatation was done using (3.5-5mm in diameter) balloons.At the end of the procedure, the arterial introducer was removed, and hemostasis was accomplished by manual compression.Of 29 patients eligible for cas, 21 (72.41%) cas procedures were done successfully for 21 patients.In total, six (20.69%) patients were shifted to cea, and two (6.90%) patients were managed with medical treatment.Technical success was achieved in all 21 (100%) complete procedures.Only one (3.45%) patient developed minor stroke (dysarthria and facial paresis) immediately after the procedure, which later improved completely within 2 days.

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: 6600176
• MDR Text Key: 76237503
• Report Number: 2183870-2017-00227
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: P060001
• 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: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/01/2017
• Initial Date FDA Received: 05/31/2017
• Supplement Dates Manufacturer Received: 05/01/2017
• Supplement Dates FDA Received: 10/04/2017
• 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
• Patient Age: 66 YR