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

Catalog Number SPD2-US-070-320

Device Problems Break (1069); Obstruction of Flow (2423); Failure to Advance (2524); Detachment of Device or Device Component (2907)

Patient Problems Embolism (1829); No Consequences Or Impact To Patient (2199); No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/23/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The physician was attempting to treat a severely calcified proximal superficial femoral artery lesion.The artery had little tortuosity and a 6-7mm diameter.The procedure used a 7 fr non-mdt sheath and a 7mm spider embolic protection filter wire.A significant amount of emboli was noted in the filter basket so it was decided to remove the spider filter.It was initially attempted to be retrieved by a 6f guide catheter without success.The filter would not go into the lumen of the guide catheter and could only semi capture the mouth of the spider.The spider was then pulled back as far as the 7 fr sheath.The physician then attempted to pull the spider into the sheath when the spider filter broke off of the wire.The basket stayed logged in the sheath.The sheath and basket were pulled out together.Case was finished after removal.

Manufacturer Narrative

Evaluation summary: the spiderfx embolic protection device filter assembly, only, was received for evaluation.No ancillary devices or cine images from the procedure were received.The distal assembly was received with biological debris from the procedure.The distal filter assembly was placed in a tub of water in a sonicating bath to loosen up the debris to allow further examination of the filter.With the aid of a microscope, it was noted that the spiderfx capture wire separated at the proximal radiopaque marker.No damage was noted to the floppy distal tip and coil assembly.Additional information: no snare was used to retrieve the device.It has been reported that the patient is doing fine.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

The physician was attempting to treat a severely calcified proximal superficial femoral artery lesion.The artery had little tortuosity and a 6-7mm diameter.The procedure used a 7 fr non-mdt sheath and a 7mm spider embolic protection filter wire.A significant amount of emboli was noted in the filter basket so it was decided to remove the spider filter.It was initially attempted to be retrieved by a 6f guide catheter without success.The filter would not go into the lumen of the guide catheter and could only semi capture the mouth of the spider.The spider was then pulled back as far as the 7 fr sheath.The physician then attempted to pull the spider into the sheath when the spider filter broke off of the wire.The basket stayed logged in the sheath.The sheath and basket were pulled out together.Case was finished after removal.

• Brand Name: SPIDER FX
• 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: 7741752
• MDR Text Key: 116217751
• Report Number: 2183870-2018-00408
• Device Sequence Number: 0
• Product Code: NFA
• Reporter Country Code: US
• PMA/PMN Number: K063785
• 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,Followup,Followup
• Report Date: 11/12/2018
• 2 Devices were Involved in the Event: 1 2

2 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2019
• Device Catalogue Number: SPD2-US-070-320
• Device Lot Number: A572737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 0