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-10-7-40-135 manufactured by Covidien.
[173699634]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[173699635]
Physician intended to use a prot? G? Rx self-expanding stent with a non-medtronic 8f guiding sheath to treat a 35mm plaque lesion in the patient? S mid common carotid artery of diameter 6. 5-9mm. Moderate vessel calcification and tortuosity are reported. A spider fx embolic protection device 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 performed using a 5x30 pre-dilation device. The stent was not passed through a previously deployed stent. No resistance was encountered during advancement. It is reported the stent dislodged during delivery to the lesion. The dislodged stent was removed. The physician made a cut and removed the stent and then converted to open surgery. No further injury reported.
Patient Sequence No: 1, Text Type: D, B5
[175499539]
Additional information: there was no injury to the patient. No additional stent was placed to treat the lesion. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183870-2020-00001 |
| MDR Report Key | 9537609 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-02 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-12-20 |
| Date Mfgr Received | 2020-03-27 |
| Device Manufacturer Date | 2019-02-07 |
| 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 |
| Returned To Mfg | 2020-03-19 |
| Catalog Number | SEPX-10-7-40-135 |
| Lot Number | A779312 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 |