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

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

Patient Problems Bradycardia (1751); Intracranial Hemorrhage (1891); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Unspecified Nervous System Problem (4426)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

Title: predictors of carotid artery stenting-induced hemodynamic instability author: mahmood saleh, haitham ali, khaled atalla journal: vascular and endovascular surgery year: 2021 vol/issue: 55(5) ref: doi: 10.1177/15385744211005654 age or date of birth: average age.Sec: majority gender.Date of event: date of publication journal reported death but there is no information to suggest the device caused or contributed to the death events.Deaths are common occurrences in clinical studies, however the cause(s) of death are often not characterized or clearly associated with a particular product.Therefore, deaths will not be considered reportable unless clearly stated as being associated with a medtronic device.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a retrospective study of prospectively collected data of patients who underwent carotid artery stenting (cas)for atherosclerotic carotid artery stenosis.728 patients were included in the study.Medtronic¿s spider fx embolic protection device, mo.Ma cerebral protection device, cristallo ideale stent, and protégé rx stents were used during procedures.The procedure was technically successful in all 728 cases.227 patient¿s developed periprocedural hemodynamic instability (hi).190 patients developed only hypotension, 18 patients developed only bradycardia, and 19 patients developed both.In 61 of the 227 patients who developed hi, adjunctive atropine or vasopressor treatment was required for management of bradycardia or persistent hypotension, respectively.Periprocedural complications occurred in 27 patients 19 patients developed periprocedural neurologic deficits.Nine patients had full resolution of neurologic deficits at the time of hospital discharge, 9 patients were discharged with residual neurologic deficits, whereas 1 patient died of massive cerebral haemorrhage.Eight patients experienced myocardial infarction in the periprocedural period.During the study period, 3 patients died due to cerebral haemorrhage and myocardial infarctions.There were no statistically significant differences in periprocedural morbidity or mortality between the 2 cohorts.There is no established or suspected causal relationship between the device(s) and the death events.

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: SPIDER FX
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC 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 ; EI ; 091708734
• MDR Report Key: 12471291
• MDR Text Key: 280684016
• Report Number: 2183870-2021-00335
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K063204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male