MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2018-11-23 for SPIDER RX UNK-PLY-SPIDERRX manufactured by Covidien.
[128196108]
Age at event: mean age. Date of event: date of article. Presentation to the forty-first annual symposium of the society for clinical vascular surgery, miami, fla, march 12-16, 2013. J vasc surg. 2014 february; 59 (2): 359? 367. E1. Doi: 10. 1016/j. Jvs. 2013. 07. 119. Https://doi. Org/10. 1016/j. Jvs. 2013. 07. 119. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[128196109]
The study involved 566 patients. Patients treated for femoropopliteal endovascular interventions, treatment of the contralateral limb and reinterventions in a previously treated limb between 2002 and 2012 were used in the study. Indications for endovascular revascularization were claudication or critical limb ischemia. Endovascular interventions consisted of angioplasty, self-expanding stent grafts, primary or secondary stenting (ptas) and percutaneous atherectomy. The spider rx 3-7mm and 6mm was used with a 0. 35 catheter, terumo sheath, 0. 018 boston guidewire. Two patients had decreased flow caused by embolic protection. In one patient filter retrieval was difficult using the 0. 014 wire, which prompted routine use of the double wire technique. Failure of the spider rx included malposition, undersizing, dislodgement during retrieval. Patients presented with embolization, occlusion, formation of platelet or thrombus emboli beyond the filter device, amputation. Patients had moderate debris in the filter basket. In one patient, possible embolization occurred during retrieval of the spider. A second patient with a thrombus emboli, the cause of which was thought to have originated beyond the spider due to stagnant flow or inadequate systemic heparinization. The two patients who had small emboli did not require intervention. Methods: we reviewed the clinical data of 566 patients treated by 836 endovascular femoropopliteal interventions for lower extremity claudication (46%) or critical limb ischemia (54%) from 2002 to 2012. Outcomes were analyzed in 74 patients/ 87 interventions performed with epds (spider rx, covidien, plymouth, mn) and 513 patients/ 749 interventions performed without epds. Tasc classification, run-off scores and embolic events were analyzed. End-points were morbidity, mortality, re-intervention, patency and major amputation rates. Results: both groups had similar demographics, indications, cardiovascular risk factors and run-off scores, but patients treated with epds had significantly (p 0. 05) longer lesions (109? 94 vs 85? 76mm) and more often had occlusions (64% vs 30%) and tasc c/d lesions (56% vs 30%). Embolic events occurred in 35 of 836 interventions (4%), including 2 (2%) performed with epd and 33 (4%) without epd (p=0. 35). Macroscopic debris was noted in 59 (68%) filter baskets. Embolic events were not associated with lesion length, tasc classification, run-off scores, treatment type or indication, but were independently associated with occlusion. Patients who had embolization required more re-interventions (20% vs 3%, p. 001) and major amputations at 30-days (11% vs 3%, p=0. 02). There was no difference in hospital stay (2. 4? 4 vs 1. 6? 2 days, p=0. 08), re-intervention (2% vs 4%) and major amputation (1% vs 4%) among patients treated with or without epd, respectively. The two patients who developed embolization with epds had no clinical sequela and required no re-intervention. Most emboli were successfully treated by catheter aspiration or thrombolysis, but 8 patients (24%) treated without epd required prolonged hospital stay, 7 (21%) had multiple re-interventions, 1 (3%) had unanticipated major amputation, and 1 (3%) died from hemorrhagic complications of thrombolysis. Median follow up was 20 months. At 2-years, primary patency and freedom for re-intervention was similar for tasc a/b and tasc c/d lesions treated with or without epds. Conclusions: rates of embolization are low in patients undergoing endovascular femoropopliteal interventions with (4%) or without (2%) epd. Embolization is more frequent in patients with occlusions. While emboli in patients with epd had no clinical sequel, those treated without epd require multiple re-interventions in 21% or resulted in major amputation or death in 3%.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183870-2018-00525 |
| MDR Report Key | 8099553 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2018-11-23 |
| Date of Report | 2019-02-07 |
| Date of Event | 2013-03-12 |
| Date Mfgr Received | 2019-02-06 |
| Date Added to Maude | 2018-11-23 |
| 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 | SPIDER RX |
| Generic Name | DEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, FOR EMBOLIZATION PROTEC |
| Product Code | NFA |
| Date Received | 2018-11-23 |
| Catalog Number | UNK-PLY-SPIDERRX |
| 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 | 2018-11-23 |