MAUDE Adverse Event Report: COVIDIEN PROTEGE RX CAROTID STENT SYSTEM; STENT, CAROTID

Catalog Number SEPX-7-30-135

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician attempted to use a protégé rx stent for patient treatment on the right distal common carotid artery.The lesion was severely calcified with moderate tortuosity.There was 90% lesion stenosis.There was no damage noted to the packaging and no issues when removing the device from the hoop/tray.There was no resistance encountered when advancing the device and no excessive force was used.The device did not pass through a previously-deployed stent.It was reported that the stent dislodged during the delivery to/at the lesion.The stent was removed and replaced with another protégé rx 7x40 stent to complete the procedure.There was no patient injury reported.

Manufacturer Narrative

Additional information: the stent did not dislodge within the patient.The stent did not deploy at all.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 rx was received within its opened labeled shelf carton, along with its opened labeled pouch, and loosely coiled/placed within its transportation tray.No ancillary devices nor procedural images were received for analysis.The protégé rx stent delivery system, (sds), was received with the outer sheath pulled away from the distal tip of the sds exposing the first half stent strut row.It appears that after the stent struts were exposed that the outer was slid distally to stop further deployment of the stent.A 0.014¿ compatible guidewire was loaded through the distal tip and would only navigate to the distal edge of the sds outer sheath.The 0.014¿ was loaded through the primary wire rapid exchange port and would only navigate to the distal edge of the sds outer sheath.Upon closer examination it appears that the guidewire lumen is kinked at the distal edge of the sds outer sheath.The guidewire e lumen most likely kinked during the removal process or post-procedure given how the device was packaged for return.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 RX CAROTID STENT SYSTEM
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 10331612
• MDR Text Key: 201852070
• Report Number: 2183870-2020-00231
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2022
• Device Catalogue Number: SEPX-7-30-135
• Device Lot Number: A977485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: 10/01/2020; 10/06/2020
• Supplement Dates FDA Received: 10/02/2020; 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR