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

Catalog Number PRP35-08-150-120

Device Problems Difficult to Remove (1528); Activation Problem (4042)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/13/2019

Event Type  Injury  

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 protege everflex stent to treat calcified, non tortuous lesion in the mid left common iliac artery.The lesion was pre-dilated with a 6 x 140mm device.There was no damage noted to the packaging and no issues noted when removing the device from the tray.The device was prepped without issue.No embolic protection was used.The device did not pass through a previously deployed stent and no resistance was encountered or force applied during delivery of the device to the lesion.It was reported that when the stent had deployed by approximately one-third, the physician tried to withdraw the stent but this failed.The physician then tore down the stent and in so doing he extracted the undeployed part from the body.The deployed part of the stent remained in the body.The physician then took an 8 x 100mm everflex stent and implanted it in the body without any issue.The procedure was reported as completed and the patient is doing good.There was no patient injury reported.

Manufacturer Narrative

Additional information: the thumbscrew was checked prior to procedure.The lock pin was removed when the stent was ready to be released.The physician removed the delivery system and in so doing he extracted the undeployed part from the body.There was no cut down needed.The fractured piece of the stent remained in the body.The physician treated the lesion with the 8 x 100mm everflex stent and covered the residual stent.The lesion was post dilated.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation visual inspection: the protégé everflex was removed from the pouch and inspected.Approximately 5 cm of the inner assembly was advanced outside the distal rim of the catheter shaft.The approximate 2cm of the stent was exposed outside the distal rim of the catheter shaft.The distal end of the stent was fractured off.The distal tantalum spheres of the distal end of the stent were fractured off from the end of the stent.The distal rim of the catheter outer showed white crystalized material consistent with that of dried contrast soliton.It should be noted, the spacing between the stent struts suggests the stent was stretched out distally.The proximal end of the stent which remained loaded the catheter shaft was approximately 10cm from the distal end of the catheter shaft.A kink was discovered at approximately 32 cm from the distal tip and 115cm from the distal tip.The locking pin was loose with the deployment grips advanced.Functional testing: the protégé everflex was attempted to be loaded over a 0.035" guidewire.The gw could not ad vance past the distal kink.With the gw partially loaded, the catheter was placed inside the deployment apparatus in the lab.It was unable to deploy further.The attempted deployment force ended at 3.51 lbs.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG
• Type of Device: STENT, ILIAC
• 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: 8619092
• MDR Text Key: 145346325
• Report Number: 2183870-2019-00268
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110023
• 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,Followup
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2021
• Device Catalogue Number: PRP35-08-150-120
• Device Lot Number: A643534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2018
• 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