MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-02 for PROTEGE RX CAROTID STENT SYSTEM SEPX-8-6-40-135 manufactured by Covidien.
[173725970]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[173725971]
Physician used a prot? G? Rx with a 5mm spider fx embolic protection device during treatment of a plaque lesion in the patient? S common carotid artery. Slight vessel tortuosity reported. Lesion exhibited 75% stenosis. No damage noted to packaging prior to use. No issues noted when removing the device from the packaging. Ifu was followed, device prepped without issue. Pre-dilation was not performed. Resistance was encountered when advancing the device. No excessive force was used. Deployment issues were noted. Lock-pin was removed at time of attempted deployment. It is reported that stent began to deploy at target location, but stent migrated from the common carotid artery bifurcation to the internal carotid artery leading to vessel spasm and stroke. Sub-acute stent thrombosis is reported. The patient was given vasodilator drugs. A non-medtronic stent was placed to keep the vessel open. No further injury reported.
Patient Sequence No: 1, Text Type: D, B5
[175499438]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[175499496]
Additional information: no stent movement/removal attempts will be made. Patient is reported to be well. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183870-2020-00003 |
| MDR Report Key | 9538189 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-02 |
| Date of Report | 2020-03-20 |
| Date of Event | 2019-12-21 |
| Date Mfgr Received | 2020-03-19 |
| Device Manufacturer Date | 2019-08-19 |
| Date Added to Maude | 2020-01-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TONI O'DOHERTY |
| Manufacturer Street | PARKMORE BUSINESS PARK WEST |
| Manufacturer City | GALWAY |
| Manufacturer Phone | 091708734 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 4600 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55442 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROTEGE RX CAROTID STENT SYSTEM |
| Generic Name | STENT, CAROTID |
| Product Code | NIM |
| Date Received | 2020-01-02 |
| Catalog Number | SEPX-8-6-40-135 |
| Lot Number | A884503 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 4600 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-02 |