MAUDE Adverse Event Report: COVIDIEN SPIDER FX; CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE

Device Problem No Apparent Adverse Event (3189)

Patient Problems Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Date 06/15/2020

Event Type  Injury  

Manufacturer Narrative

Title: the use of embolic protection devices during lower extremity peripheral vascular interventions author: cassius iyad ochoa chaar; tanner i.Kim; fatma m.Shebl journal: annals of vascular surgery year: 2020 vol/issue: 69 ref: 10.1016/j.Avsg.2020.06.014.Average age.Majority gender.Majority race date of publication journal reported death but there is no information to suggest the device caused or contributed to the death events.Deaths are common occurrences in clinical studies, however the cause(s) of death are often not characterized or clearly associated with a particular product.Therefore, deaths will not be considered reportable unless clearly stated as being associated with a medtronic device.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a study to assess the use and outcomes of epds during peripheral vascular interventions (pvi).10,646 pvi were performed during the study period.Medtronics spider fx embolic protection device was used during a range of procedures involving balloon angioplasty, self-expanding stent, balloon-expanding stent, cutting balloon, laser atherectomy, orbital atherectomy, excisional atherectomy.Anatomical locations treated include aorta, common iliac, external iliac, common femoral, profunda, superficial femoral, popliteal, anterior tibial, tibioperoneal trunk, posterior tibial, and peroneal.Approx.1.7 arteries treated per procedure.Technical success is reported in 96.75 of procedures within the epd group.Within the epd group, clinical events of distal embolization, thrombosis, and major amputation and death are reported.There is no established or suspected causal relationship between the spider fx and and the death events.

• Brand Name: SPIDER FX
• Type of Device: CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE
• 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 ; EI ; 091708734
• MDR Report Key: 11130421
• MDR Text Key: 225500231
• Report Number: 2183870-2021-00011
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2021
• 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: 68 YR