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

Catalog Number	PRB35-06-150-120
Medical Device Problem Codes	Break (1069); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician used a protégé everflex with a 6fr non-mdt sheath and a non-medtronic 0.035¿ guidewire during treatment of a 150 mm cto plaque lesion in the mid right superficial femoral artery(sfa).The lesion was reported to have exhibited little tortuosity and little calcification.The device was prepped as per ifu without issue.The stent was advanced to the intended target location.The physician proceeded to loosen safety pin on the stent, then he pinned the proximal grip and began to retract the distal grip toward the proximal grip.The stent then flowered and midway through deployment, the physician felt resistance and then a sudden release as the two grips met.On flouro exam, the stent was difficult to see as only a small portion had deployed.The markers on the distal end of stent were also difficult to see.There were no further actions that would allow any further deployment of the stent.An attempt was made to remove the catheter but when it arrived at the sheath opening it could not be retracted further.Under fluoro examination, it could be seen that the stent had pulled into the common iliac with the catheter.Resistance continued to be felt so the physician attempted to try to recapture it by reapproximating the delivery catheter grips.The stent, however, remained attached to the catheter.The physician attempted to pull the catheter and stent through the sheath and the catheter came back but had what appeared to be part of the stent remaining in the catheter.On fluoro exam the detached portion of the stent was distal to the sheath in the iliac vessel.Angioplasty was performed to stabilize the detached portion of the stent with a 6 x 150 balloon.After angioplasty the distal markers of the stent were more visible than they had been previously.No further intervention was required.
Additional Manufacturer Narrative
Device evaluation: the protégé everflex self-expanding peripheral stent system was received for evaluation.No ancillary devices or cine images from the procedure were received for evaluation.The protégé everflex stent delivery system, (sds), was received with the deployment paddles in contact with each other and the safety locking pin was loose.Sanguine residue was observed within the stopcock tube.The stainless steel hypotube was exposed beyond the manifold¿s printed strain relief indicating that the bond between the outer sheath and the manifold has been breached.A portion of the distal inner assembly was exposed and a few stent struts were observed protruding from the distal end of the sds outer sheath.The exposed distal assembly and protruding stent struts indicate that the stent was partially deployed and then fractured in an attempt to remove the sds from the patient.Back lighting of the outer sheath was conducted to locate the proximal end of the stent and to confirm that the stent remained engaged with the stent retainer.Approximately 125mm of the 150mm length stent remain within the sds outer sheath.The proximal end of the outer sheath has a straight machine cut indicating that the adhesive bond between the outer sheath and the manifold has been exposed to a force equal to or greater than 5-lbs.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7402743
• Report Number: 2183870-2018-00210
• Device Sequence Number: 13461632
• Product Code: FGE
• UDI-Device Identifier: 00821684069264
• UDI-Public: 00821684069264
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K060057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2018

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: 09/23/2018
• Device Catalogue Number: PRB35-06-150-120
• Device Lot Number: A164410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Initial Date Received by Manufacturer: 03/08/2018
• Supplement Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 07/03/2018
• 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