MAUDE Adverse Event Report: MEDTRONIC, INC GUARDWIRE TEMPORARY OCCLUSION SYSTEM; CATHETER, EMBOLECTOMY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Embolism/Embolus (4438)

Event Date 09/03/2018

Event Type  Injury  

Manufacturer Narrative

Title: carotid artery stenting for patients with occipital¿vertebral anastomosis.Year: 2019 reference: doi:10.1177/1591019918802924.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted for review titled: carotid artery stenting for patients with occipital¿vertebral anastomosis.The purpose of the article was to report the outcomes of carotid artery stenting (cas) for patients with angiographically visible occipital artery¿vertebral artery anastomosis.Seven patients were selected.Four different protection methods were used: distal internal carotid artery protection; carotid flow reversal; seatbelt and airbag technique; and double protection method of protecting both the external and internal carotid artery.Seat belt and air bag technique: after carotid flow reversal a non medtronic embolic protection device was deployed in the distal internal carotid artery (ica).The medtronic percusurge guardwire in the external carotid artery (eca) was deflated and pulled away.The balloon of the guiding catheter was deflated, completing protection.Double protection method: a medtronic percusurge guardwire was used to protect the occipital artery (oa) and the eca.A bilateral transfemoral approach was used and 8-fr and 5-fr guiding catheters were placed into the common carotid artery (cca) together.The medtronic guardwire was placed through the 5-fr guiding catheters in the eca proximal to the oa origin and the non medtronic embolic protection device was advanced and deployed at the distal ica through the 8-fr catheter.Subsequently, the medtronic guardwire was inflated to protect both the oa and eca.After stent placement procedures were completed, both the balloon and filter were deactivated while continuous blood aspiration was performed from the 8-fr launcher guide catheter to eliminate debris pooling beneath the protection balloon.Then the protection balloon was pulled back outside the expanded stent.Stent placement procedures were successfully completed in all cases.Patient 1 was treated with the distal ica protection method using the medtronic guardwire.The patient presented with a large oa¿va anastomosis with cas being completed only using the distal ica protection balloon.Postoperative diffusion-weighted imaging (dwi) s howed a small, high-intensity lesion (embolic particle) at the border of the upper surface of the thalamus, internal capsule and wall of the lateral ventricle body without ischemic symptoms.Patient 3 was treated with the distal ica protection method using the non medtronic embolic protection device.The patient presented with high-intensity lesions on postoperative dwi in the right frontal lobe with no ischaemic symptoms after cas.Patient 6 underwent the double protection method during cas using the non mdt embolic protection device and guardwire.The patient showed no additional high-intensity lesion postoperative dwi.Patient 2 (flow reversal method) used the non medtronic device and guardwire.Patient 4 and 5 (distal ica protection method) used the non mdt embolic protection device.Patient 7 (seat belt and air bag method) used cello and guardwire but dwi could not be performed due to pacemaker implantation.

• Brand Name: GUARDWIRE TEMPORARY OCCLUSION SYSTEM
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14598690
• MDR Text Key: 293341716
• Report Number: 1220452-2022-00041
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K023878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2022

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/05/2022
• Initial Date FDA Received: 06/03/2022
• 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 Age: 70 YR
• Patient Sex: Male