MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 635 VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC

Catalog Number	ZIV6-35-125-6-80
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/03/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Pma/510(k)#: p050017/s002 and s003.From the additional information provided for this complaint file, it is known that an amplatz 0.35 inch wire guide was used during this procedure.The device was flushed through both flushing ports before the procedure and pre dilatation was conducted before stent deployment.The physician deployed the stent in the patient.The user answered ¿no¿ to the following question: was the target site severely calcified / tortuous anatomy.Prior to distribution all ziv6-35-125-6-80 devices are subjected to visual inspection and functional checks to ensure device integrity.A review of the manufacturing records revealed no discrepancies related to or which could have contributed to this complaint issue.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.
Event or Problem Description
The zilver stent deployed prematurely and was deployed in an unintended location.The safety lock was still in place.
Additional Manufacturer Narrative
User facility contact number: (b)(4).Pma/510(k)#: p050017/s002 and s003.The 1x ziv6-35-125-6-80 device of lot number c914226 was returned for evaluation.Device was not returned in the original packaging and was open on receipt.On inspection of the returned device, it was found that the stent had been deployed.According to additional information it was confirmed that the stent deployed prematurely with the safety tab on.The safety tab was removed after the stent was deployed.The red safety tab was not returned with the delivery system.Using a calibrated ruler the outer sheath measured 124.8 cm and was noted to be as per specification.The entire delivery system was visually inspected, and it was noted that the outer sheath had separated from the handle indicating high deployment forces.Additional information has been requested regarding when the outer sheath separated from the handle however to date no further information has been provided.The user indicated that there was slight resistance during the procedure but nothing abnormal.No manufacturing issues were observed during the lab evaluation.As there is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.During the lab evaluation it was noted that the outer sheath had separated from the handle of the complaint device.It is possible excessive force was required during the procedure which led to the outer sheath separating from the handle and the stent prematurely deploying in the patient.However, as the conditions of use could not be replicated in the laboratory setting, a definitive root cause of this premature deployment cannot be determined.Upon examination of the returned device, there is no evidence to suggest that the device was manufactured incorrectly.From the additional information provided for this complaint file, it is known that an amplatz 0.35 inch wire guide was used during this procedure.The device was flushed through both flushing ports before the procedure and pre dilatation was conducted before stent deployment.The user answered ¿no¿ to the following question: was the target site severely calcified / tortuous anatomy? the user did not attempt to deploy the stent, the stent deployed prematurely with the safety tab on.As the stent deployed prematurely in an unintended location, the physician decided to monitor the situation and no further action was required.The safety tab was removed after the stent was deployed.The customer indicated that there was slight resistance during the procedure but nothing abnormal.Prior to distribution all ziv6-35-125-6-80 devices are subjected to visual inspection and functional checks to ensure device integrity.A review of the manufacturing records revealed no discrepancies related to or which could have contributed to this complaint issue.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.As the stent deployed prematurely in an unintended location, the physician decided to monitor the situation and no further action was required quality engineering will continue to monitor complaints of this nature for potential emerging trends.
Event or Problem Description
This follow up report is being submitted due to the receipt and evaluation of the device involved in this event.Initial description submitted as follows: the zilver stent deployed prematurely and was deployed in an unintended location.The safety lock was still in place.

• Brand Name: ZILVER 635 VASCULAR SELF-EXPANDING STENT
• Common Device Name: NIO STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 5534077
• Report Number: 3001845648-2016-00079
• Device Sequence Number: 833845
• Product Code: NIO
• UDI-Device Identifier: 10827002438238
• UDI-Public: (01)10827002438238(17)160816(10)C914226
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2016

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 Catalogue Number: ZIV6-35-125-6-80
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/03/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2016
• Supplement Report FDA Received Date: 05/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1