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

Catalog Number SEPX-8-6-40-135

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2019

Event Type  malfunction  

Manufacturer Narrative

Protege rx was returned for evaluation loaded an 8f non-medtronic sheath.No other ancillary devices were included.The tip assembly was observed exposed outside the distal end of the introducer.The distal portion of the stent was also exposed.The tantalum markers were observed protruding out from the distal rim of the sheath.There was no indication of a stent fracture.The introducer sheath showed buckling throughout the shaft.Primarily at the proximal and distal ends.The buckling was consistent with encountered resistance during withdrawal.The deployment grip was positioned advanced consistent with intended deployment of the stent.The stent was inspected under microscope and verified no fractures to the stent struts were observed.Areas of buckling of the introducer sheath were inspected under microscope.A bend to the protege rx shaft was observed proximal to the introducer approximately 6cm from the shaft.The protégé rx was attempted to be advanced outside of the introducer, but the device was stuck and could not be moved in either direction.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician was attempting to use a protege rx stent along with a spider fx embolic protection in the treatment of moderately calcified plaque lesion in the left proximal common carotid artery with 80% stenosis.The device was prepped per ifu with no issues identified.It was reported that during an attempt to deploy the stent, it was not able to be deployed.It was removed out along the guide wire and a new stent was used to complete the procedure.There was no patient injury reported.

Manufacturer Narrative

Corrected: date mfr rec to: 13.12.2019 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: 9480185
• MDR Text Key: 195300876
• Report Number: 2183870-2019-00590
• 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
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2020
• Device Catalogue Number: SEPX-8-6-40-135
• Device Lot Number: A655626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR