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

Catalog Number SPD2-040-320

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Dizziness (2194); Patient Problem/Medical Problem (2688); Vascular Dissection (3160)

Event Date 03/21/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician was using a spiderfx embolic protection device while treating a moderately calcified plaque lesion with 85% stenosis in the distal common carotid artery.Moderate tortuosity was reported.There was no abnormality in relation to patient¿s anatomy.The vessel was pre-dilated.The ifu was followed.It was reported that during initial advancement resistance was encountered and the tip of the device embolised in the patient at the target lesion.The detached piece was captured within the sheath.It was also reported that there was vessel damage and a dissection occurred.Another spider device was used to complete the procedure.

Manufacturer Narrative

Additional information patient developed symptoms of dizziness and required interventional therapy.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: image 1 and 2 shows the filter observe outside of the distal section of the green dual ended delivery catheter.This likely occurred after the spiderfx device was removed out of the patient.The catheter was observed to be occluded with red biological material.The distal tip wire was present, and the coil shows no evidence of uncoiling.Filter assembly appears to be intact.Cine 1 shows the filter is fully deployed in the vessel.The proximal radiopaque marker band and the distal radiopaque marker band are visible.There is evidence of contrast in the targeted vessel.Base on the cine quality, we are unable to confirm a tip detachment and vessel dissection.However, based on image 1 and 2 received, the distal tip wire is present, and the coil shows no evidence of uncoiling.Filter assembly appears to be intact.If information is provided in the future, a supplemental report will be issued.

• 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 ; 091708734
• MDR Report Key: 8455648
• MDR Text Key: 139988221
• Report Number: 2183870-2019-00149
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K063204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: SPD2-040-320
• Device Lot Number: A654403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2019
• Date Device Manufactured: 06/01/2018
• 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: 65 YR
• Patient Weight: 75