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

Catalog Number	SECX-10-7-30-135
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Physician attempted to use a protege rx self-expanding stent to treat patient in the right, proximal common carotid artery.Lesion type was calcified with severe tortuosity, severe calcification and 90% stenosis.Artery diameter was 6 mm and lesion length was 25 mm.A 4 mm balloon was used to pre-dilate.It is reported that post-stent deployment, removal difficulties were experienced with the delivery system due to heavily calcified internal carotid and tortuosity.The delivery catheter caught on the stent causing stent deformation.A 0.035", 4 x 40 admiral balloon was used to dilate the stent and next to the delivery system.Balloon and device were then removed.No patient history reported.
Additional Manufacturer Narrative
Additional information received: it was reported that the balloon used post-deployment was used because of the stent deformation and not as a normal part of the procedure.Evaluation summary: the protégé rx was returned for evaluation.The protégé rx was inspected and observed it was in a post-deployment state.The inner assembly was advanced past the outer assembly.The deployment grip was pushed forward.The strain relief was removed from the catheter.Blood was noted within the clear manifold assembly and the hypotubing.The distal tip, exposed inner assembly, retainer, and outer assembly were inspected.No damage was noted; dried blood was noted within the outer assembly.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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTEGE RX CAROTID STENT SYSTEM
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 6441919
• Report Number: 2183870-2017-00147
• Device Sequence Number: 1042098
• Product Code: NIM
• UDI-Device Identifier: 00821684038710
• UDI-Public: 00821684038710
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P060001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: SECX-10-7-30-135
• Device Lot Number: A154915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Initial Date Received by Manufacturer: 03/02/2017
• Supplement Date Received by Manufacturer: Not provided; 03/27/2017
• Initial Report FDA Received Date: 03/29/2017
• Supplement Report FDA Received Date: 04/25/2017; 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR