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 Intracranial Hemorrhage (1891); Thromboembolism (2654); Vascular Dissection (3160)

Event Date 01/19/2021

Event Type  Injury  

Manufacturer Narrative

Journal title: direct aspiration thrombectomy experience with the sofia 6f catheter in acute ischemic stroke japanese journal of radiology (2021) 39:605¿610.Https://doi.Org/10.1007/s11604-021-01090-z.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a study which aimed to evaluate the usefulness of a non-medtronic (sofia) 6f catheter in mechanical thrombectomy with the direct aspiration first pass technique.148 patients were included in the study.Medtronic¿s spider fx and protégé rx devices were used in the study.During procedures with tandem occlusions (19 patients) the stenotic segment was passed with a guidewire, and spiderfx embolic protection device was deployed in the terminal segment of the cervical ica.Subsequently, emergency percutaneous transluminal balloon angioplasty using a non-medtronic balloon was performed for the stenotic segment.If balloon angioplasty failed to achieve luminal patency, then additional carotid stenting with protege rx was performed to allow mechanical thrombectomy.A protégé rx stent was placed in 2 patients.After achieving adequate luminal patency, the non-medtronic (sofia) 6f was navigated to the thrombus site, and direct aspiration thrombectomy was performed.All patients were followed up in an inpatient setting and evaluated by a multidisciplinary team on a regular basis.Thromboembolic complications in new territories occurred in 8 cases.After treatment, a symptomatic intracranial hemorrhage (sich) was observed in 8 patients.In three cases, intracranial dissection was detected after the use of the stent retriever.The mortality rate after the procedure was 14.1%.There is no established or suspected causal relationship between the device(s) and the death events.

• 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 ; EI ; 091708734
• MDR Report Key: 12343553
• MDR Text Key: 267312156
• Report Number: 2183870-2021-00302
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• 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: 08/16/2021
• 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 Age: 64 YR