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

Catalog Number SEPX-9-40-135

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician intended to use a protégé rx carotid stent with a non-medtronic 8fr sheath and 0.014 spider fx embolic protection device during treatment of a calcified and plaque cto (chronic total occlusion-100%) in the patient¿s proximal right common carotid artery.Severe vessel calcification and tortuosity are reported.There was no damage noted to the product packaging prior to use.No issues were noted when removing the device from the packaging.Ifu was followed and the device was prepped without issue.Pre-dilation was not performed.No resistance was noted during delivery to the lesion.The device was not passed through a previously deployed stent.The thumbscrew/lock-pin was checked for securement prior to procedure and removed prior to attempted deployment.It is reported the stent could not be deployed.Resistance was felt during device removal from the patient.After the deflexion, it was removed successfully.It is reported that the stent was deployed in the sheath and a little part was out, and it was deployed completely by the doctor when taken out of the body for testing.The device was replaced with another medtronic stent to complete the procedure.No patient injury reported.

Manufacturer Narrative

Product analysis: the protégé rx device was returned to medtronic investigation lab for evaluation.The device was received within a sealed biohazard bag.Within the biohazard bag, the device was loosely contained within the opened sterile label pouch.No ancillary device was returned.The device was removed from the return packaging.The device was returned in a post-deployment state.The retainer was pulled back into the outer sheath.The stent was returned for examination.A dried blood like substance was noted in the returned device.Multiple bends and kinks were observed throughout the outer distal assembly.Multiple bends/kinks were located approximately 2.6cm, 6.2cm, 7.8cm, 8.1cm, 8.8cm, 9.4cm, 11.7cm, 12.7cm, 13.4cm, 94.5cm, 101.6cm, and 134.4cm.Microscopic examination revealed no anomalies with the stent retainer legs.The stent retainer was then pushed through the outer assembly for visual inspection.Multiple kinks were observed in the inner distal assembly.The kinks were located approximately 1.8cm, 2.7cm, and 3.6cm proximal to the distal tip.The stent measured approximately 40mm in length, consistent with the reported device.No anomalies were noted with the deployed stent.Image review: a single photographic image was received of the protégé rx stent delivery system, (sds), on top of its opened labeled pouch and the 9mm by 40mm stent is deployed just above the pouch label in the picture.The outer sheath of the sds is in contact with the distal tip of the sds.No compacted stent is visible within the distal end of the sds outer sheath.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: 10552148
• MDR Text Key: 207512324
• Report Number: 2183870-2020-00298
• 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: 11/12/2020

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: 11/04/2021
• Device Catalogue Number: SEPX-9-40-135
• Device Lot Number: A926574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 10/27/2020
• Supplement Dates FDA Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1