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

Model Number SPD2-US-030-320

Device Problems Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician intend to use a spider fx embolic protection device with a 6fr non-medtronic sheath and 0.018 non-medtronic guidewire during treatment of a calcified lesion in the patient¿s mid right superficial femoral artery, popliteal artery, and tibial/popliteal trunk.Ifu was followed.Pre-dilation was not performed.It is reported that the spider was delivered over the 0.018 non-medtronic wire (the filter was pulled back into appropriate window to allow for no wire interaction).The spider fx was advanced smoothly to the target area and the 0.018 wire was removed without issue.The physician then began advancing the filter wire and no issues were noted.When the physician looked on fluoro, it was observed that the filter had not advanced and under fluoro the spider would not advance past marker (believe that is where rx exit port is located).The tip of wire looked to have an angle on it and wanting to exit that port under fluoro.It was decided that remove the filter and delivery catheter from patient.The catheter would not come back into sheath, it could be advanced but not come back without extreme force.Upon investigation under fluoro it was noticed that the spider wire itself had prolapsed into iliac and was causing the sheath to pull back and not allowing the device to be removed.The sheath was removed but the wire itself had become so entangled that it could not be safely removed from the artery.Physician at that time had to a surgical cutdown on the groin to access the artery and create area for the device to be removed.Once removed, the spider wire had the appearance of a bird¿s nest with all the entanglement.The patient was reported to be fine but did have to get put under anaesthesia and have a surgical cutdown performed.

Manufacturer Narrative

Device evaluation: the spiderfx catheter was received with a portion of the capture wire detached.The detachment of the capture wire occurred at the catheter access point.The filter was observed within the clear segment.The remaining portion of the capture wire was returned and all components were accounted for.Due to the detachment to the capture wire, it is unable to advance the filter out of the catheter.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.

Manufacturer Narrative

Additional information: the filter never passed through the target lesion.The patient had to be given more anesthesia to undergo the surgical cutdown to remove the device.All components of the device were removed from the patient.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.

Manufacturer Narrative

Additional information: the lesion presented 80-90% stenosis.The catheter went past lesion but the filter itself looked as if it never moved from the clear chamber of catheter.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: 10654904
• MDR Text Key: 210603094
• Report Number: 2183870-2020-00323
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 00821684068304
• UDI-Public: 00821684068304
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2022
• Device Model Number: SPD2-US-030-320
• Device Catalogue Number: SPD2-US-030-320
• Device Lot Number: A989250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR