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

Catalog Number SPD2-040-190

Device Problems Fracture (1260); Detachment of Device or Device Component (2907); Positioning Problem (3009)

Patient Problem Injury (2348)

Event Date 12/05/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician was attempting to use a spider fx embolic protection device during procedure to treat a severely calcified lesion in the right mid common carotid artery with chronic total occlusion (cto-100%).The vessel diameter and lesion length were 2.5mm and 4cm respectively.The vessel was little tortuous.During the carotid artery stenting (cas) procedure, spider filter catheter was used but it failed to pass the stenosis site.The catheter was stuck at the most stenosed site, and it was removed when pulling it, but platinum marker which was mounted on the tip of the catheter fractured, and it remained inside the patient¿s body.Physician attempted to remove the dislodged marker using a suction catheter unsuccessfully.Two carotid stents were implanted to cage the marker.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: the guiding catheter (gc) became kinked on the aorta.The spider fx catheter became stretched as a result of this.The platinum marker was difficult to observe on fluoroscopy.A non-medtronic balloon was used to push the broken marker portion into the ic stenosis.The detached portion had not entered the distal region.The two stents implanted were non-medtronic stents.No further intervention required.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: the spider fx was returned inside a previously opened spider fx box.No ancillary devices were included.The spider fx was inspected and found the capture wire loaded the green delivery catheter.The delivery catheter was fractured off at the end.The fractured off segment was not returned.The fracture was ductile in nature consistent with exposure to excessive tensile forces.The delivery catheter was stretched and flattened at the distal portion of the returned segment approximately 5cm from the distal fracture face.Bends and kinks were also discovered.The filter assembly was identified within the green delivery catheter approximately 20 cm from the fracture face.The capture wire could not be advanced in order to inspect the filter assembly, likely due to the damages to the delivery catheter image review: the customer provided multiple cine images and photos affiliated with the reported event.Cine images 1 and 2: the suspected stenosis site has like been identified.At area of the stenosis vessel shows a suspected radiopaque marker.The identified radiopaque marker is like from the distal tip of the delivery catheter.A fracture could not be identified.Cine images 3 and 4: the cine image was inconclusive.The quality and the clarity of the provided images could not distinctly identify components of the spider fx.A photo of the spider fx box was provided and indicated lot a909014, which is consistent with the reported lot number.The customer provided a photo of two delivery catheter lined up next to each other.The length according to the ruler next to the catheters indicate a length of 13cm.One distal end shows the distal end fractured off.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: 9444393
• MDR Text Key: 170690926
• Report Number: 2183870-2019-00567
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• PMA/PMN Number: K063204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/13/2020

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
• Device Expiration Date: 08/12/2021
• Device Catalogue Number: SPD2-040-190
• Device Lot Number: A909014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: 12/10/2019; 12/16/2019; 02/12/2020
• Supplement Dates FDA Received: 12/11/2019; 12/19/2019; 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention