MAUDE Adverse Event Report: COVIDIEN SPIDER RX; DEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, FOR EMBOLIZATION PROTEC

Catalog Number UNK-PLY-SPIDERRX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Occlusion (1984); Thrombus (2101); Patient Problem/Medical Problem (2688)

Event Date 03/12/2013

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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%.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPIDER RX
• Type of Device: DEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, FOR EMBOLIZATION PROTEC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8099553
• MDR Text Key: 128196108
• Report Number: 2183870-2018-00525
• Device Sequence Number: 1
• Product Code: NFA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063785
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-PLY-SPIDERRX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR