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 2020-02-05 for SPIDER FX manufactured by Covidien.
[178355197]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[178355198]
This article aims to evaluate the frequency of primary obstruction events (pro) during one-year follow-up after performing excisional atherectomy with the silverhawk/turbohawk atherectomy device s/th or remote superficial femoral artery endarterectomy (rsfae) in patients with the chronic superficial femoral artery occlusive disease (sfaod). All randomized clinical trials (rcts) and not-rcts concerning the treatment of patients with sfaod after s/th and rsfae without duration. 27 articles on the levels of evidence were included in qualitative synthesis; 9 studies (meta-analysis) were included in quantitative synthesis. The results of 2762 patients? Treatment were evaluated. Primary obstruction events (pro) reported were restenosis and occlusion during one-year follow-up with target lesion revascularization carried out to treat the restenosis and occlusion. The article reports 792 out of 2762 people experienced pro. The study concluded that s/th with the spiderfx device (distal embolic protection) are safe and effective treatment option for short lesion (15 cm) in patients with sfaod, rsfae may be considered better than an endovascular procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183870-2020-00037 |
| MDR Report Key | 9670582 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date of Event | 2019-08-28 |
| Date Mfgr Received | 2020-01-29 |
| Date Added to Maude | 2020-02-05 |
| 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 | SPIDER FX |
| Generic Name | CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE |
| Product Code | NTE |
| Date Received | 2020-02-05 |
| Lot Number | UNK |
| 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 | 2020-02-05 |