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

Model Number	G50117
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It should be noted, the intended use for this device is for palliation of malignant neoplasms in the biliary tree.This report includes information known at this time.A follow-up report will be submitted at the conclusion of the investigation or, when additional relevant information becomes available.
Event or Problem Description
It was reported, a (b)(6) female with a history of peripheral artery disease, was undergoing stent placement of a lower extremity.The zilver flex 35 biliary self-expanding stent was deployed over a wire to the lower extremity.The stent catheter was removed without excessive force when it was discovered part of the stent was still attached to the delivery system.The stent was reportedly straight and taut prior to the attempted deployment.The physician then post dilated and felt the stent was well enough opposed.The post-dilation was a planned part of the procedure and was not performed as a result of this occurrence.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.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 or Problem Description
Additional information was received on 20sep2019.As reported, access was gained in the left groin to target a lesion in the right lower extremity.Stent deployment was performed in a "typical fashion." resistance was reported when the stent was partially (3/4) deployed.On removal of the delivery system, the stent broke into two pieces, one of which remained in the delivery system.The delivery system was thereafter successfully removed.No further information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation/evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), specifications, and quality control procedures of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.A document-based investigation evaluation was thus conducted.There is no evidence to suggest the product was not otherwise made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Furthermore, reviews of the specifications, drawings, and quality control procedures were conducted, and no gaps were discovered.The device is packaged with instructions for use (ifu), which state, ¿the zilver flex 35 biliary stents are intended for palliation of malignant neoplasms in the biliary tree.¿ based on the information provided and no product returned, investigation has concluded that the device failure could be attributable to the device¿s reported off-label in use in the patient¿s lower extremity.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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
• MDR Report Key: 8604705
• Report Number: 1820334-2019-01137
• Device Sequence Number: 19297137
• Product Code: FGE
• UDI-Device Identifier: 10827002501178
• UDI-Public: (01)10827002501178(17)200718(10)8098329
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K080037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2019

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: 07/18/2020
• Device Model Number: G50117
• Device Catalogue Number: ZIB6-35-80-6-100
• Device Lot Number: 8098329
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 09/20/2019; 10/13/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 10/11/2019; 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR