MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 518 VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC

Model Number	G43777
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # = p050017/s002 and s003.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.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
The complaint ziv5-18-125-7-60 was used for evt.The access was obtained from the femoral artery.When the physician delivered the device with a contralateral approach, the radiopaque marker of the proximal tip on the sheath became out of position while the radiopaque markers on the distal tip and a stent did not move.The physician continued to use the complaint device and ended the procedure.There were no other problems, and the patient reportedly experienced no adverse effects on this incident.Updated on april 2, 2019 by (b)(6): the proximal radiopaque marker on the inner catheter became out of position.The proximal radiopaque marker on the inner catheter became out of position while the distal radiopaque marker of the sheath and the radiopaque marker on the stent did not move.
Additional Manufacturer Narrative
Pma/510(k) #: p050017/s002 and s003.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)(6).Cook medical incorporated (cmi): (b)(4).Importer site establishment registration number: (b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
The complaint (b)(4) was used for evt.The access was obtained from the femoral artery.When the physician delivered the device with a contralateral approach, the radiopaque marker of the proximal tip on the sheath became out of position while the radiopaque markers on the distal tip and a stent did not move.The physician continued to use the complaint device and ended the procedure.There were no other problems, and the patient reportedly experienced no adverse effects on this incident.Updated on april 2, 2019 by (b)(6).The proximal radiopaque marker on the inner catheter became out of position.The complaint (b)(4) was used for evt.The access was obtained from the femoral artery.When the physician delivered the device with a contralateral approach, the proximal radiopaque marker on the inner catheter became out of position while the distal radiopaque marker of the sheath and the radiopaque marker on the stent did not move.The physician continued to use the complaint device and ended the procedure.There were no other problems, and the patient reportedly experienced no adverse effects on this incident.
Additional Manufacturer Narrative
Pma/510(k) #: p050017/s002 and s003.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.Device evaluation: the ziv5-18-125-7-60 device of lot number c1245177 involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 11apr2019.Incorrect wire guide used.Document review: prior to distribution all zilver ziv5-18-125-7-60 devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records (c1245177) 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 that there are any manufacturing issues associated with lot number c1245177.There is evidence to suggest that the customer did not follow the instructions for use.¿introduce the extra or ultra stiff wire guide(7.0 and 6.0 french [2.3 and 2.0mm] systems accept 0.035 inch [0.89mm] wire guide; 5.0 french [1.67mm] system accepts 0.018 inch [0.046mm] wire guide) through the access catheter across the distal segment of the target lesion.A 0.014-inch command (hydrophyllic) wire guide was used.Root cause review a definitive root cause of incorrect wire guide selection was identified from the available information.Summary: there is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
The complaint ziv5-18-125-7-60 was used for evt.The access was obtained from the femoral artery.When the physician delivered the device with a contralateral approach, the radiopaque marker of the proximal tip on the sheath became out of position while the radiopaque markers on the distal tip and a stent did not move.The physician continued to use the complaint device and ended the procedure.There were no other problems, and the patient reportedly experienced no adverse effects on this incident.Updated on april 2, 2019 by (b)(6): the proximal radiopaque marker on the inner catheter became out of position the complaint ziv5-18-125-7-60 was used for evt.The access was obtained from the femoral artery.When the physician delivered the device with a contralateral approach, the proximal radiopaque marker on the inner catheter became out of position while the distal radiopaque marker of the sheath and the radiopaque marker on the stent did not move.The physician continued to use the complaint device and ended the procedure.There were no other problems, and the patient reportedly experienced no adverse effects on this incident.

• Brand Name: ZILVER 518 VASCULAR SELF-EXPANDING STENT
• Common Device Name: NIO STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8598537
• Report Number: 3001845648-2019-00201
• Device Sequence Number: 1998232
• Product Code: NIO
• UDI-Device Identifier: 10827002437774
• UDI-Public: (01)10827002437774(17)190628(10)C1245177
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2019

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: 06/28/2019
• Device Model Number: G43777
• Device Catalogue Number: ZIV5-18-125-7-60
• Device Lot Number: C1245177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/10/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 04/15/2019; 04/15/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 06/06/2019; 07/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1