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

Catalog Number SPD2-050-320

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

Patient Problems Death (1802); Blood Loss (2597)

Event Date 09/26/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

Physician used a hawkone atherectomy device with a spider fx embolic protection device, 7fr non-medtronic sheath and 3 non-medtronic guidewires (0.014, 0.018, and 0.035) during treatment of a chronic total occlusion (cto) in the patient¿s left superficial femoral artery (sfa).Ifu was followed.The patient had an atherectomy planned procedure to treat a non-healing ulcer.A cto lesion is reported to have been present at the left proximal sfa head.The spider fx was placed in the distal sfa, no tortuosity was present, however there was a stiff acute bifurcation.It is reported the sheath had some issues traversing.Heavy calcification is reported at the proximal cap of the cto (approximately 15cm) long.Atherectomy was performed as per ifu on between 5-10cm of the calcified lesion.Upon final imaging, there was no bleeding, and patient's foot was pulsatile.A 7fr non-medtronic closure device was used.There were no unusual/defective characteristics with the medtronic devices noted.Approximately 10 hours post procedure the patient experienced symptoms and a bleed in the groin was observed.The patient was taken to surgery, and it was noted there was no swelling in either groin.Right groin, not much found (i.E.No reason for a bleed), left groin, not much found, but on further exploration, there was a bleeding 'rent' in the back wall (posterior) of the sfa.Patient death is reported.Cause of death reported as retro-peritoneal bleeding.

Manufacturer Narrative

It is unknown if the spider fx and/or the hawkone was suspected to have contributed to the bleeding leading to the patient's death.It is unknown what part of the procedure caused the death.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: CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 10704027
• MDR Text Key: 212083998
• Report Number: 2183870-2020-00340
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• PMA/PMN Number: K111010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2022
• Device Catalogue Number: SPD2-050-320
• Device Lot Number: B049474
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 74 YR