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

Model Number	G50167
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Advance (2920); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
As reported, during treatment of a chronic total obstruction in the right superficial femoral artery (sfa), a zilver flex 35 biliary self-expanding stent would not deploy.Access was obtained in the left common femoral artery.The lesion was crossed with another manufacturer's wire guide and a cook 5 french, 55-centimeter ansel sheath, and was then ballooned with a cook 35lp balloon.The anatomy was not severely tortuous or calcified.Another manufacturer's 6x15 stent was placed on the distal end of the sfa, as defection flaps were noted.An arteriogram was obtained and the physician needed to extend the other manufacturer's stent.The complaint device was then inserted, after flushing the device, and was noted to get "caught up" on the other manufacturer's stent while watching the arteriogram.The physician pushed the device forward with more force.Upon attempted deployment of the stent, it would not deploy.The device was removed and a ptx stent was used to complete the procedure, with no further complications.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during treatment of a chronic total obstruction in the right superficial femoral artery (sfa), a zilver flex 35 biliary self-expanding stent would not deploy.Access was obtained in the left common femoral artery.The lesion was crossed with another manufacturer's wire guide and a cook 5 french, 55-centimeter ansel sheath, and was then ballooned with a cook 35lp balloon.The anatomy was not severely tortuous or calcified.Another manufacturer's 6x15 stent was placed on the distal end of the sfa, as defection flaps were noted.An arteriogram was obtained and the physician needed to extend the other manufacturer's stent.The complaint device was then inserted, after flushing the device, and was noted to get "caught up" on the other manufacturer's stent while watching the arteriogram.The physician pushed the device forward with more force.Upon attempted deployment of the stent, it would not deploy.The device was removed and a ptx stent was used to complete the procedure, with no further complications.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, documentation, instructions for use (ifu), and manufacturing instructions were conducted during the investigation.A visual inspection and functional test of the returned device was also conducted.The complaint device was returned to cook for investigation.The stent was returned fully deployed separately and the red safety lock was not returned.A functional inspection found the device flushed with no issue and a 0.035-inch wire guide passed through with no issue.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other related complaints associated with the complaint device lot.Because there were no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in the field.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: precautions: ¿manipulation of the product requires high-resolution fluoroscopic control.Do not attempt to push the handle away from the hub during deployment.¿ instructions for use: ¿using fluoroscopic visualization, insert the introducer catheter over the wire guide.Position the catheter so that the distal and proximal radiopaque markers on the stent (i) are at the desired position.The stent is now ready to be deployed.Deployment of the stent: ¿the stent expansion must be performed under fluoroscopic control.¿ multiple stent placement: ¿in relation to the lesion site, the distal area of narrowing should be stented first, followed by the proximal locations (i.E., a second stent should by placed proximally to the previously placed stent.)¿ ¿the zilver 518 and 635 biliary stent has been designed for use in palliation of malignant neoplasms in the biliary tree.¿ cook concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, ifu, and investigation of the return device suggests that there is evidence the device was manufactured to specification.Based on the available information and results of the investigation, cook has concluded that off label use contributed to this event.The user has not complied with the requirements of the ifu with respect to the intended use of the device.It should be noted that because the device was used outside of the validated state and against the instructions provided in the ifu, it is not possible to predict how the device will perform or function.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT
• Common Device Name: 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: 14114557
• Report Number: 1820334-2022-00573
• Device Sequence Number: 14771472
• Product Code: FGE
• UDI-Device Identifier: 10827002501673
• UDI-Public: (01)10827002501673(17)230908(10)13460661
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K080037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/08/2023
• Device Model Number: G50167
• Device Catalogue Number: ZIB6-35-125-6-140
• Device Lot Number: 13460661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDTRONIC VISIPRO 6X15 STENT; TERUMO GLIDEWIRE
• Patient Sex: Female