MAUDE Adverse Event Report: COVIDIEN PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD; CATHETER, BILIARY, DIAGNOSTIC

Catalog Number	PRB35-08-080-120
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Atherosclerosis (1728); Patient Problem/Medical Problem (2688)
Date of Event	02/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: the protege everflex self-expanding peripheral stent system was received for.No ancillary devices or cine images from the procedure were received for evaluation.The protégé stent delivery system, (sds), was received with approximately 33 mm of the 80 mm stent.Sanguine fluid was noted within t he stopcock tube.The deployment paddles were received in contact with each other and the outer sheath was pulled back its full proximal direction exposing the stent retainer of the inner distal assembly.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting to use an everflex entrust stent to treat a 20 mm moderately calcified plaque lesion (80% stenosis) in the right proximal common iliac artery.The artery diameter was 7 mm in diameter and was moderately tortuous.The device was prepped as per the ifu with no issues identified.The procedure used a 5 fr sheath and a 0.035¿ guidewire.The lesion was pre-dilated using a 6 mm pre-dilation device.It was reported that there was no difficulty encountered advancing the device, no excessive force was used and the device did not pass through a previously deployed stent.During deployment of the stent it was reported that the physician couldn¿t see the sheath and the deployed stent across the lesion and in the sheath.The physician then experienced difficulty removing the stent delivery system (sds).The physician could not see the tip of the access sheath.The stent elongated when the sds and sheath were removed.The stent separated - half of the stent remained in the sheath and on sds.The rest of the stent was elongated and pulled through the arteriotomy.It was reported that hemostasis was controlled by placing a new sheath.An endarectomy was performed to remove the stent from the arteriotomy and to close the vessel.The patient was reported to be doing well.

• Brand Name: PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7365852
• Report Number: 2183870-2018-00182
• Device Sequence Number: 19274625
• Product Code: FGE
• UDI-Device Identifier: 00821684060261
• UDI-Public: 00821684060261
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K060057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2018

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: 01/15/2021
• Device Catalogue Number: PRB35-08-080-120
• Device Lot Number: A581592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 03/23/2018
• 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: 57 YR
• Patient Weight: 66