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

Model Number	G50169
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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, a zilver flex 35 biliary self-expanding stent, reportedly placed in the superficial femoral artery on (b)(6) 2018, was found to be fractured.The stent was "relined" with an unknown cook zilver ptx stent.Another manufacturer's previously-placed stent was also found to have multiple fractures and was relined with a zilver ptx stent.The vessels were reportedly patent and the patient is stable.
Event or Problem Description
Additional information was received 04oct2019 regarding the device event.As reported, the stent was replaced in the proximal superficial femoral artery.Pre-dilation was performed prior to stent placement, and post-dilation was performed following stent placement.A cook 6fr sheath was used during the procedure.No further information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown 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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Initial report as reported, a zilver flex 35 biliary self-expanding stent, reportedly placed in the superficial femoral artery on (b)(6) 2018, was found to be fractured.The stent was "relined" with an unknown cook zilver ptx stent.Another manufacturer's previously-placed stent was also found to have multiple fractures and was relined with a zilver ptx stent.The vessels were reportedly patent and the patient is stable.Investigation - evaluation reviews of the complaint history, device history record, documentation, instructions for use (ifu), quality control procedures, and specifications of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.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 and quality control procedures were conducted, and no gaps were discovered.The available evidence does not suggest a manufacturing issue for this lot.An ifu is provided with this device, which states the intended use of the device is for palliation of malignant neoplasms in the biliary tree.The ifu also warns the user ¿safety and effectiveness of this device in the vascular system have not been established¿.Based on the information provided and no product returned, investigation has concluded that this event can likely be traced to the user and intentional off label use.Reportedly, this stent was placed in the superficial femoral artery, contrary to the warning of the ifu.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: 9124964
• Report Number: 1820334-2019-02429
• Device Sequence Number: 11377568
• Product Code: FGE
• UDI-Device Identifier: 10827002501697
• UDI-Public: (01)10827002501697(17)210316(10)8749749
• 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
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2020

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: 03/16/2021
• Device Model Number: G50169
• Device Catalogue Number: ZIB6-35-125-7-120
• Device Lot Number: 8749749
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2019
• Supplement Date Received by Manufacturer: 10/04/2019; 03/10/2020
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 10/28/2019; 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BARD LIFESTENT.; BARD LIFESTENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR