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

Model Number	G43832
Medical Device Problem Codes	Break (1069); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195 importer site establishment registration number: 3005580113 pma/510(k) # p050017/s002 and s003 the ziv6-35-125-8-60 of lot c1220100 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document based investigation was conducted.On evaluation of the returned device, it was observed that the red safety tab was not returned with the device.The flexor had separated from the handle at the white cap.The flexor was measured as 125.8cm, which was within specification of 125cm +1.3cm -0.8cm.The device was flushed from the hub, and wired with a 0.035¿ diameter wire guide, with no issues.The device was returned with the stent already deployed.There was no tactile damage on the flexor.The customer complaint is confirmed, as the flexor was observed to be separated from the handle.Possible causes for this occurrence could include a difficult patient anatomy.The patient anatomy could have caused high deployment forces during the use of the product.These forces could have caused or contributed to the flexor separating from the handle.However, as the conditions of use cannot be replicated in a laboratory environment and the information has not yet been provided, a definitive root cause for this occurrence cannot be determined.Prior to distribution all ziv6 (zilver 635) devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this lot number.Based on the information available to date, there is no evidence to suggest any issues with lot c1220100.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
An attempt was made to deploy the zilver 635 vascular self-expanding stent.As they were pulling back the handle on the delivery system, the sheath did not retract over the stent.The flared part of the sheath separated from the plastic delivery hub.The device was removed, another device was used to complete the procedure with no adverse effects to the patient.
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to mfr site as follows: importer site contact and address: (b)(6).Importer site establishment registration number: 3005580113.Pma/510(k) # p050017/s002 and s003.The ziv6-35-125-8-60 of lot c1220100 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document based investigation was conducted.From customer testimony, it is known that the target location for the device was the iliac artery.The device was advanced over a uniglide wire guide of 0.035¿ diameter wire guide.Resistance was not encountered when advancing the wire guide or device to the target location.The patient anatomy was calcified.There are no images available from the procedure.The device was not advanced through the previously placed stent.The stent was shipped with the delivery system.On evaluation of the returned device, it was observed that the red safety tab was not returned with the device.The flexor had separated from the handle at the white cap.The flexor was measured as 125.8cm, which was within specification of 125cm +1.3cm -0.8cm.The device was flushed from the hub, and wired with a 0.035¿ diameter wire guide, with no issues.The device was returned with the stent already deployed.There was no tactile damage on the flexor.The customer complaint is confirmed, as the flexor was observed to be separated from the handle.Possible causes for this occurrence could include a difficult patient anatomy.From customer testimony, it is known that patient anatomy was calcified.The patient anatomy could have caused high deployment forces during the use of the product.These forces could have caused or contributed to the flexor separating from the handle.However, as the conditions of use cannot be replicated in a laboratory environment, a definitive root cause for this occurrence cannot be determined.Prior to distribution all ziv6 (zilver 635) devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this lot number.Based on the information available to date, there is no evidence to suggest any issues with lot c1220100.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
This follow up mdr is being submitted due to the receipt and review of additional information relating to this event.Additional information received on 01-aug-17 as follows: what was the target location for the complaint device? - iliac.Wire guide details (make, diameter, hydrophilic etc.) - 035 260cm angled uniglide.Was resistance encountered when advancing the wire guide to the target location? - no.Was resistance encountered when advancing the complaint device to the target location? - no.Was the patient anatomy calcified or tortuous? - yes, calcified.Are there any images of the procedure? - no.Was the device advanced through a previously placed stent? - no.The device was returned without the stent.Can the customer account for the location of the stent? - the device and stent were returned together.The stent, delivery system, and product box were placed into a plastic bag which was then placed into a box and shipped back to cook.Initial report details: an attempt was made to deploy the zilver 635 vascular self-expanding stent.As they were pulling back the handle on the delivery system, the sheath did not retract over the stent.The flared part of the sheath separated from the plastic delivery hub.The device was removed, another device was used to complete the procedure with no adverse effects to the patient.

• 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: 6633311
• Report Number: 3001845648-2017-00220
• Device Sequence Number: 16146110
• Product Code: NIO
• UDI-Device Identifier: 10827002438320
• UDI-Public: (01)10827002438320(17)190414(10)C1220100
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2017

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 Model Number: G43832
• Device Catalogue Number: ZIV6-35-125-8-60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/16/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/16/2017
• Supplement Date Received by Manufacturer: 08/01/2017
• Initial Report FDA Received Date: 06/12/2017
• Supplement Report FDA Received Date: 08/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1