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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Stroke/CVA (1770)

Event Date 08/16/2021

Event Type  Injury  

Event Description

A journal article was submitted titled: ¿tailor-made¿ total cerebral protection during transcatheter aortic valve implantation.The study evaluated the safety and feasibility of our total cerebral protection methods using embolic protection devices (epds) for carotid artery stenting.In case 5, the anterior communicating artery and the posterior communicating artery were not confirmed on magnetic resonance angiography (mra) which indicated low potential of collateral flow when the brachiocephalic artery was temporarily occluded with a balloon.Due to the embolic risk, an anterograde approach to the right carotid artery was planned through the same guiding catheter used to protect the left carotid artery, via the left femoral access route.The right vertebral artery was protected via the right brachial artery.A medtronic spiderfx was deployed in the right internal carotid artery, a non mdt embolic protection system was deployed in the left internal carotid artery, and a spiderfx was deployed in the left vertebral artery.The right vertebral artery was also protected with a carotid guardwire.A head mri on the day after the procedure showed new ischemic lesions.Asymptomatic acute cerebral infarctions were detected.During the case 5 procedure, dislodgement of the protection devices was also reported but the protection system was re-deployed easily.

Manufacturer Narrative

Journal article: ¿tailor-made¿ total cerebral protection during transcatheter aortic valve implantation authors: keita suzuki, masaomi koyanagi, shinichi shirai, hideo chihara, takenori ogura, takahiro kamata, taisuke kitamura, kenji ando, and taketo hatano journal: neurologia medico chirurgica (tokyo) year: 2021 reference: doi: 10.2176/nmc.Oa.2021-0005.Date of event: date of publication.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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: 13859136
• MDR Text Key: 287661747
• Report Number: 1220452-2022-00022
• 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: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/16/2022

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2022
• Initial Date FDA Received: 03/23/2022
• Supplement Dates Manufacturer Received: 04/27/2022
• Supplement Dates FDA Received: 05/16/2022
• 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: 85 YR
• Patient Sex: Male