MAUDE Adverse Event Report: COVIDIEN PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number PRB35-05-040-120

Device Problems Entrapment of Device (1212); Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician attempted to use a protégé everflex stent to treat a soft tissue plaque with little calcification and unknown % lesion stenosis in the left mid tibial/popliteal trunk.The artery diameter was 5mm and lesion length was 40 mm.The stent was applied to trap clot, chronic total occlusion was located in the sfa.There were no abnormalities reported in relation to anatomy.A 6f 45cm non-medtronic sheath french and wholey wire were used.No embolic protection was used.There was no damage noted to packaging (i.E.Shelf carton, hoop/tray).There were no issues noted when removing the device from the hoop/tray.The device was prepped per the ifu with no issues identified.The lesion was not pre-dilated.The device passed through a previously-deployed stent.No resistance was encountered when advancing the device and no excessive force was used.It is reported that a break/fracture occurred at the catheter tip.The stent catheter was pulled out of the patient after deployment and the tip was noticed on fluoroscopy.The component emb olized in the vessel.The detached portion of device did not remain in the patient and was removed with a snare, the patient was not harmed.There were there no patient symptoms or complications associated with this event.

Manufacturer Narrative

Additional information: there was no issue with the stent itself.There was no vessel damage noted.There was no additional treatment given.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

Product analysis: the protégé everflex stent delivery system, (sds), was received within a nested series of sealed plastic biohazard pouches along with a portion of its shelf carton label, and tightly coiled within a zippered closure pouch.No ancillary devices nor procedural images were received for evaluation.The protégé everflex sds was received with the deployment paddles in contact with each other which pulled back the sds outer sheath exposing the distal end of the inner guidewire distal assembly.A visual audit of the protégé sds, revealed approximately 1cm of the inner guidewire lumen and the sds distal tip were not returned.Per the initial reported event description, the distal tip was snared out of 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.

• Brand Name: PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 10223549
• MDR Text Key: 197339001
• Report Number: 2183870-2020-00202
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00821684068540
• UDI-Public: 00821684068540
• Combination Product (y/n): N
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/01/2020

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: 02/12/2021
• Device Model Number: PRB35-05-040-120
• Device Catalogue Number: PRB35-05-040-120
• Device Lot Number: A597256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Initial Date Manufacturer Received: 06/25/2020
• Initial Date FDA Received: 07/02/2020
• Supplement Dates Manufacturer Received: 07/10/2020; 09/30/2020
• Supplement Dates FDA Received: 07/14/2020; 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 108