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

Catalog Number	SPD2-US-040-320
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	08/03/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician used a spider fx embolic protection device during a procedure to treat the sfa.It was reported that the spider filter detached from the wire following lasering and pta ballooning of the lesion.The detached portion was successfully retrieved by the physician with a snare, however during the retrieval it was reported that the physician ¿dinged up a stent¿ and then later lost blood flow to the vessel.This was a pre-existing coronary stent used as a ¿bailout¿ in the tpt trunk, placed in 2015.It was reported that the spider fx device may have gotten tethered or pulled by the stent that the "dinging of the stent" or the longitudinally compression likely came later as a result of the snare attempts.The stent is still in situ.Blood flow was lost antegrade down the vessel.Attempts were made to restore the blood flow, but unable to get through the stent.Physician suspected that the subintimal entry of the guidewire may have caused intramural hematoma with loss of flow.It was reported that the blood flow to the vessel was compromised while manipulating the stent to optimize the proximal expansion; it was not directly due to the spider or the snare.Multiple attempts were made to cross and re-cross the stent.Physician tried retrograde posterior tibial access but was unsuccessful.The procedure was then aborted.The patient returned 10 days later to treat the other leg.Physician revisited the same leg and was successful in accessing the posterior tibial artery and then via retrograde approach get through the stent, balloon angioplasty, re-expand and restore antegrade flow that was previously there.The patient is reported as being fine.
Additional Manufacturer Narrative
Device evaluation summary: the spiderfx device was returned.Ancillary device 0.014in guidewire was returned with the spiderfx device.The device was returned without the spider filter and capture wire assembly.Visual inspection of the white distal tip of the green delivery catheter revealed no abnormalities or deformities.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPIDER FX
• Common Device Name: CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 6840549
• Report Number: 2183870-2017-00371
• Device Sequence Number: 10794349
• Product Code: NTE
• UDI-Device Identifier: 00821684068328
• UDI-Public: 00821684068328
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K111010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/12/2017
• Device Catalogue Number: SPD2-US-040-320
• Device Lot Number: A172549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Initial Date Received by Manufacturer: 08/04/2017
• Supplement Date Received by Manufacturer: 08/04/2017
• Initial Report FDA Received Date: 09/02/2017
• Supplement Report FDA Received Date: 12/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention