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

Catalog Number SEPX-8-6-40-135

Device Problems Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/11/2021

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the device returned coiled in a biohazard pouch.Device was decontaminated with cidex opa solution soak and tergazyme soak.The device was returned with the distal portion of the shaft missing.It appears that the detachment happened at the rx port.No functional testing could be carried out due to the condition of the returned device.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician was attempting to use protege rx self-expanding stent along with an 8fr non-medtronic sheath, 0.014" spider guidewire and spider 5mm embolic protection during procedure to treat a non calcified plaque lesion in the left proximal common carotid artery with 100% stenosis in the internal carotid artery interlayer.The vessel was none tortuous.The vessel diameter and lesion length are 6-8mm and 30mm respectively.There was no damage noted to packaging.There was no issue noted when removing the device from the hoop/tray.The device was prepped per ifu with no issues identified.Deployment issue occurred with physician unable to deploy stent.The was no resistance encountered during delivery to lesion.The device did not pass through a previously deployed stent.The thumb switch/lock-pin was checked for securement prior to procedure.The lock-pin was removed before deployment.Physician replaced with a stent of the same model of medtronic and deployed smoothly.There was no patient injury.The device was returned with the distal portion of the shaft missing.

• Brand Name: PROTEGE RX CAROTID STENT SYSTEM
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12428227
• MDR Text Key: 273167980
• Report Number: 2183870-2021-00320
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/06/2021

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: 12/23/2022
• Device Catalogue Number: SEPX-8-6-40-135
• Device Lot Number: B137916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2021
• Initial Date FDA Received: 09/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 47 YR