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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Hole In Material (1293)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
A zilver flex 35 biliary self-expanding stent was used in an arteriogram.It was reported that the stent was placed over the wire and partially deployed when it broke.The distal part of the broken stent remains in the anterior tibial artery.A balloon was used and another stent was placed to complete the procedure.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any other adverse effects due to this occurrence.
Additional Manufacturer Narrative
During evaluation of the complaint device on 16jan2018, a hole was observed in the zilver flex 35 biliary self-expanding stent tubing.(b)(4).The stent was flushed through both flushing ports prior to the procedure.A balloon was put through the complaint device and inflated to "seat" the stent better in the artery.Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, trends, quality control, functional testing, and visual inspection of the returned device was conducted during the investigation.One used zilver flex 35 biliary self-expanding stent was returned for evaluation, without the original packaging.The device was returned without the stent; damage was observed on the flexor.The device was flushed through the hub, with no issues found.The device was then flushed through the stent nesting area, and water was seen exiting where the flexor was damaged.A 0.035 inch diameter wire guide was unable to be passed through the device.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.There is no information regarding the preparation of the device prior to use.Per the ifu, ¿do not attempt to remove the stent from the introducer system before use.Ensure that the red safety lock is not inadvertently removed until final stent release.¿ there is no information regarding the wire guide used during this procedure.Per the ifu, ¿deploy the stent over an extra stiff or ultra stiff wire guide.¿ the customer was unable to confirm if the user pulled the handle toward the hub during deployment.Per the ifu, ¿do not attempt to push the handle away from the hub during deployment.¿ it is unknown if there was severe calcification or tortuous anatomy or if pre-dilatation was performed before stent deployment.A tortuous or calcified anatomy could create resistance during deployment and cause/ or contribute to damage to the device.From the information provided, it appears that the complaint device was used in an arteriogram, suggesting that the device was used in the cardiovascular system, contrary to indications for use.Per the ifu, "the zilver 518 and 635 biliary stents are intended for palliation of malignant neoplasms in the biliary tree." based on the information provided, examination of the returned product, and the results of our investigation, a definite root cause could not be determined; however, it is likely that use of the stent in a non-indicated location contributed to this event.Per the risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.

• 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: 6880248
• Report Number: 1820334-2017-03191
• Device Sequence Number: 1142757
• Product Code: FGE
• UDI-Device Identifier: 10827002501666
• UDI-Public: (01)10827002501666(17)181013(10)6301996
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ZIB6-35-125-6-120
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/14/2017
• Supplement Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 01/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention