MAUDE Adverse Event Report: COOK INC ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number G50170

Device Problems Premature Activation (1484); Off-Label Use (1494)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/05/2022

Event Type  malfunction  

Event Description

As reported, during a procedure involving placement of a stent within a lesion in the superficial femoral artery, a zilver flex 35 biliary self-expanding stent partially deployed.The heavily calcified lesion was crossed and pre-dilated with an unknown balloon.The complaint device was then introduced into the patient over an unknown 0.035-inch wire and through an unspecified 6 french, 45-centimeter sheath; however, the user reported that the delivery device seemed to be caught up in the sub-intima.The device was removed from the patient, at which point the user noticed that the stent was partially deployed.At no time was any part of the complaint device/stent left in the patient.Another stent of the same size was then deployed and the procedure was completed successfully.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: b5, h3: (other): device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Additional information was received 27may2022.The vessels were both calcified and tortuous.An unknown amplatz wire was used with the device.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Summary of event: as reported, during a procedure involving placement of a stent within a lesion in the superficial femoral artery, a zilver flex 35 biliary self-expanding stent partially deployed.The heavily calcified lesion was crossed and pre-dilated with an unknown balloon.The complaint device was then introduced into the patient over an unknown 0.035-inch wire and through an unspecified 6 french, 45-centimeter sheath; however, the user reported that the delivery device seemed to be caught up in the sub-intima.The device was removed from the patient, at which point the user noticed that the stent was partially deployed.The vessels were both calcified and tortuous.An unknown amplatz wire was used with the device.At no time was any part of the complaint device/stent left in the patient.Another stent of the same size was then deployed and the procedure was completed successfully.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Corrected information: h6 (annex a and g) investigation evaluation: reviews of the complaint history, instructions for use (ifu), manufacturing instructions, and documentation were conducted during the investigation.A visual inspection and functional test of the returned device were also conducted.The complaint device was returned to cook for investigation without the original packaging.The red safety lock was in place and the stent was partially deployed at the tip of the device.A functional test was conducted and the stent could not be deployed due to resistance felt at the handle.A 0.035 inch wire was able to pass through the device and the device was able to be flushed.A document review was completed as a response to this event.Prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.A review of the device history record (dhr) recorded no relevant non-conformances.A search of complaint history on the reported lot found no additional lot related complaints from the field.The instructions for use (ifu) states "the zilver 518 and 635 biliary stent has been designed for use in palliation of malignant neoplasms in the biliary tree.¿ the information provided upon review of the dhr, ifu, and investigation of the returned device suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Based on the available information and results of the investigation, cook has concluded that off label use contributed to this event, as the device was used within the vascular system, which is off-label use for this device.The resistance encountered during the procedure may have been due to possible kinks or bends in the delivery system that could have occurred when attempting to deploy in calcified and tortuous vessels.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT
• Type of Device: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 14455488
• MDR Text Key: 300345606
• Report Number: 1820334-2022-00945
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 10827002501703
• UDI-Public: (01)10827002501703(17)240927(10)14271655
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G50170
• Device Catalogue Number: ZIB6-35-125-7-140
• Device Lot Number: 14271655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 05/27/2022; 03/10/2023
• Supplement Dates FDA Received: 06/03/2022; 04/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2021
• 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