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 2020-01-21 for PROTEGE RX CAROTID STENT SYSTEM SEPX-8-6-40-135 manufactured by Covidien.
[175867535]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[175867536]
Physician intended to use a prot? G? Rx during treatment of a 40mm plaque lesion in the patient? S proximal common carotid artery of diameter 8mm. Moderate vessel tortuosity and slight calcification are reported. Lesion exhibited 70% stenosis. Embolic protection was used. 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. No resistance was encountered when advancing the device. It is reported stent deformation occurred during positioning/deployment. The stent reached the lesion and it could not be completely deployed and resistance was met. The stent was deployed successfully after it was covered by a second stent which forcibly deployed it. The ends of the stent are reported to have deformed. An implantation of a second stent of the same model was used to cover the first stent and lesion was performed to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183870-2020-00023 |
| MDR Report Key | 9611536 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-21 |
| Date of Report | 2020-01-21 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-01-07 |
| Device Manufacturer Date | 2018-08-09 |
| Date Added to Maude | 2020-01-21 |
| 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 Country | IE |
| 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 | 2020-01-21 |
| Catalog Number | SEPX-8-6-40-135 |
| Lot Number | A689517 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-01-21 |