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

Catalog Number SEPX-8-30-135

Device Problems Fracture (1260); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the physician intended to use a protégé rx with a spider fx embolic protection device for the treatment of a 20mm severely calcified chronic total occlusion(cto-100%) lesion in the patient¿s proximal common carotid artery of diameter 8mm.It was reported to exhibit severe tortuosity.The device was prepped as per ifu with no issued identified.The lesion was pre-dilated.The physician initially performed anterior cervical stent treatment.The protégé rx was then passed through the initially deployed stent.Resistance was encountered during advancement of the device, but no excessive force was used.It was reported that the stent broke after passing the previously implanted stent.There was no damage to the previously implanted stent.All the components and the delivery catheter were taken out of the body together, and there was no debris left in the patient.The procedure was then stopped.No patient injury was reported.

Manufacturer Narrative

Evaluation summary: the protégé rx was returned for evaluation.No ancillary devices were included.The device was inspected.The tuoey-borst valve was noted to be tightened.The distal end of the stent was flowered outside the distal tip of the catheter.The outer was fractured.The distal portion of the catheter, including the distal tip, was not returned.Approximately 1 cm of the wire lumen and the stent was exposed outside of the outer catheter.No damage to the stent was observed.The stent was deployed and showed no damages.The wire lumen which had fractured showed traces of dried blood on the exposed exterior.The fracture face was ductile.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
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7543835
• MDR Text Key: 109229421
• Report Number: 2183870-2018-00289
• 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,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2018
• Device Catalogue Number: SEPX-8-30-135
• Device Lot Number: A351096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 75