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U.S. Department of Health and Human Services

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

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COVIDIEN PROTEGE RX CAROTID STENT SYSTEM; STENT, CAROTID Back to Search Results
Catalog Number SEPX-9-30-135
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/27/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was attempting to use a protege rx self-expanding stent during procedure to treat a moderately calcified plaque lesion in the common carotid artery.There was no damage to device packaging.There was no issue noted when removed device from hoop/tray.The device was prepped per ifu with no issues identified.It was reported that the stent could be deployed from the sheath.Stent struts were partially exposed outside the sheath within the patient's vessel.The device was removed from the patient without difficulty.Physician used another manufacturer's product to complete the procedure.No vessel damage reported.There was no patient injury reported.
 
Manufacturer Narrative
Image review a photo of the reported issue was received for evaluation from the customer.It was observed that the protégé rx device had the distal portion of the stent protruding out from the distal end of the catheter outer sheath.The device was loosely packed inside a biohazard pouch.The lot number written on the biohazard pouch was consistent with the reported device.Stent diameter and length printed on strain relief was 9x30 mm.Mpxr and fedex documentation were displayed.Device evaluation the protégé rx was returned for evaluation loosely packed inside a biohazard pouch.No device identification (product labeling) was included.No ancillary devices from the procedure were received for evaluation.The device was removed from the packaging and visually inspected.The device was returned in a post deployed state.The inner assembly was exposed outside the distal rim of the catheter outer and the deployment grip was advanced forward.The stent received had a length of approximately 30 mm.No abnormality or deformity was noted with the returned stent.No damage to the retainer or distal tip was noted.The device strain relief indicated that the stent diameter and length were 9 x 30 mm, consistent with the reported device.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.
 
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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 Key10571981
MDR Text Key208115387
Report Number2183870-2020-00304
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
PMA/PMN Number
P060001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/04/2020
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 Date04/17/2021
Device Catalogue NumberSEPX-9-30-135
Device Lot NumberA817066
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2020
Initial Date Manufacturer Received 09/21/2020
Initial Date FDA Received09/23/2020
Supplement Dates Manufacturer Received11/03/2020
Supplement Dates FDA Received11/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age61 YR
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