MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FILTERWIRE EZ; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Model Number 44150

Device Problem Material Integrity Problem (2978)

Patient Problems Embolism (1829); Paralysis (1997); Dysphasia (2195)

Event Date 11/20/2020

Event Type  Injury  

Event Description

It was reported that the back of the filter was damaged.The 7.3mmx2.7mmx7mm, 63% stenosed target lesion area was located in the averagely tortuous and calcified left cervical carotid artery.A 190 cm filterwire ez was selected for use in a carotid artery angioplasty with stenting procedure as a protection device.After application of heparin, the filterwire crossed the lesion and was deployed.There were no issues with the filter on contrast radiography.Upon intravascular ultrasound (ivus) with a non-boston scientific ivus catheter, fibrous plaque and high calicification in the stenosis was confirmed.Balloon angioplasty was performed and a non-boston scientific stent was placed.The lesion was dilated sufficiently, no protrusion was visible in the stent by ivus.When the filterwire was collected with the capture sheath, removal did not squeeze the captured debris.No strong resistance was felt and the filter was captured too much.Afterwards, the left middle cerebral artery (mca) m2 segment showed a shadow defect and obstruction in the intracranial, despite the fact that there was no problem with the cervical lesion.The filterwire was collected immediately as a damaged part of the filter was noted.The filter basked appeared to be separated from the filterwire shaft.The patient had right hemiparesis and aphasia.Retrieval of the embolic material was performed with a non-boston scientific stent retriever but was not able to cross the lesion.A mechanical thrombus retrieval device was used.It was thought that the embolic material was retrieved, but the obstruction was still there and the embolic material moved further to the distal.Further removal attempts were made but unsuccessful.Maneuver for retrieval was discontinued to avoid risk of vessel damage.Ct scan was done and occlusions were confirmed in the left mca and nucleus basalis.No intracranial hemmorhage was present.120,000 units of urokinase (uk) was administered from the left mca m1.The hemiparesis and aphasia improved and the patient was responding to the call.Again, 120,000 units of urokinase was injected to slow and stop the flow of the left superior trunk but it was not fully flowed.Another ct scan was done and occlusion was still confirmed and no hemorrhage.The procedure was completed, and the patient did not recover and had right hemiparesis and aphasia, but was capable to move the right upper and lower limb.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Visual and microscopic inspection revealed that the wire returned completely deployed and the customer returned the delivery and retrieval sheaths.The filter bag is ripped and the wire was kinked at 26.5 cm from the spring tip.The spring tip is stretched, curvy and bent.No failures were found on the delivery and retrieval sheaths.Media inspection was performed.The customer provided four pictures related to the complaint where it is possible to observe that the filter bag is ripped and wrinkled, and moreover, the spring tip is stretched, curvy, and bent.Dimensional inspection of the overall dimension of the proximal section, middle section, and spring tip were within specification.Functional inspection revealed that sheathing/unsheathing test cannot be performed since the wire returned totally deployed.

Event Description

It was reported that the back of the filter was damaged.The 7.3mmx2.7mmx7mm, 63% stenosed target lesion area was located in the averagely tortuous and calcified left cervical carotid artery.A 190 cm filterwire ez was selected for use in a carotid artery angioplasty with stenting procedure as a protection device.After application of heparin, the filterwire crossed the lesion and was deployed.There were no issues with the filter on contrast radiography.Upon intravascular ultrasound (ivus) with a non-boston scientific ivus catheter, fibrous plaque and high calicification in the stenosis was confirmed.Balloon angioplasty was performed and a non-boston scientific stent was placed.The lesion was dilated sufficiently, no protrusion was visible in the stent by ivus.When the filterwire was collected with the capture sheath, removal did not squeeze the captured debris.No strong resistance was felt and the filter was captured too much.Afterwards, the left middle cerebral artery (mca) m2 segment showed a shadow defect and obstruction in the intracranial, despite the fact that there was no problem with the cervical lesion.The filterwire was collected immediately as a damaged part of the filter was noted.The filter basked appeared to be separated from the filterwire shaft.The patient had right hemiparesis and aphasia.Retrieval of the embolic material was performed with a non-boston scientific stent retriever but was not able to cross the lesion.A mechanical thrombus retrieval device was used.It was thought that the embolic material was retrieved, but the obstruction was still there and the embolic material moved further to the distal.Further removal attempts were made but unsuccessful.Maneuver for retrieval was discontinued to avoid risk of vessel damage.Ct scan was done and occlusions were confirmed in the left mca and nucleus basalis.No intracranial hemmorhage was present.(b)(4) units of urokinase (uk) was administered from the left mca m1.The hemiparesis and aphasia improved and the patient was responding to the call.Again, (b)(4) units of urokinase was injected to slow and stop the flow of the left superior trunk but it was not fully flowed.Another ct scan was done and occlusion was still confirmed and no hemorrhage.The procedure was completed, and the patient did not recover and had right hemiparesis and aphasia, but was capable to move the right upper and lower limb.

• Brand Name: FILTERWIRE EZ
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10935539
• MDR Text Key: 219191155
• Report Number: 2134265-2020-16766
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 44150
• Device Catalogue Number: 44150
• Device Lot Number: 0025943535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6FR- SHUTTLE SHEATH; 6FR- SHUTTLE SHEATH; 9FR SHEATH, 9FR OPTIMO; 9FR SHEATH, 9FR OPTIMO; IVUS CATHETER - EAGLE EYE; IVUS CATHETER - EAGLE EYE; STENT - CHIKAI 014; STENT - CHIKAI 014; STENT - SHIDEN; STENT - SHIDEN; 6FR- SHUTTLE SHEATH; 9FR SHEATH, 9FR OPTIMO; IVUS CATHETER - EAGLE EYE; STENT - CHIKAI 014; STENT - SHIDEN
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 70 YR