MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 635 VASCULAR SELF-EXPANDING STENT

Model Number	G43856
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	09/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: p050017/s002 and s003.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
[on 17/sep/2019 (b)(6) added additional information].Ipsilateral approach was gained from the femoral artery.The user deployed the stent (ziv6-35-80-8-40/ c1527776) but the stent was not fully expanded (stent diameter was smaller than 8mm).Post-dilation was performed with terumo's senri 8mm balloon but the stent was still not fully expanded.Therefore, another stent(8mm x 40mm) was placed inside the complained stent and the procedure was completed.There have been no adverse effects to the patient reported.Fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent shortening/compression during deployment¿.No adverse effects to the patient have been reported as occurring.
Additional Manufacturer Narrative
Common name: nio stent, iliac.Product code: nio.Pma/510(k)#: p050017/s002 and s003.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
On [(b)(6) 2019, (b)(6) added additional information].Ipsilateral approach was gained from the femoral artery.The user deployed the stent (ziv6-35-80-8-40/ c1527776) but the stent was not fully expanded (stent diameter was smaller than 8mm).Post-dilation was performed with terumo's senri 8mm balloon but the stent was still not fully expanded.Therefore, another stent(8mm x 40mm) was placed inside the complained stent and the procedure was completed.There have been no adverse effects to the patient reported.Fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent shortening/compression during deployment¿.No adverse effects to the patient have been reported as occurring.
Additional Manufacturer Narrative
Common name: nio stent, iliac; product code: nio; pma/510(k) #: p050017/s002 and s003.Device evaluation: the ziv6-35-80-8-40 device of lot number c1527776 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 26sep2019.Three kinks on the inner catheter peek.(no new prs necessary for the kinks as they occurred during transportation, reference attachment ¿pr#: (b)(4)_extra prs not required¿.) document review: prior to distribution ziv635-80-8-40 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the relevant manufacturing records (c1527776) 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 c1527776.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0043-9).Root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause for the stent not expanding fully could be attributed to calcification of the vessel and insufficient pre-dilation.Summary: 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
[17/sep/2019 shohei kon added additonal information ].Ipsilateral approach was gained from the femoral arery.The user deployed the stent (ziv6-35-80-8-40/ c1527776) but the stent was not fully expanded (stent diameter was smaller than 8mm).Post-dilation was performed with terumo's senri 8mm balloon but the stent was still not fully expanded.Therefore, another stent(8mm x 40mm) was placed inside the complained stent and the procedure was completed.There have been no adverse effects to the patient reported.Fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent shortening/compression during deployment¿.No adverse effects to the patient have been reported as occurring.

• Brand Name: ZILVER 635 VASCULAR SELF-EXPANDING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9141821
• Report Number: 3001845648-2019-00499
• Device Sequence Number: 1927020
• Product Code: NIO
• UDI-Device Identifier: 10827002438566
• UDI-Public: (01)10827002438566(17)210811(10)C1527776
• 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): 10/30/2019

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: 08/11/2021
• Device Model Number: G43856
• Device Catalogue Number: ZIV6-35-80-8-40
• Device Lot Number: C1527776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/03/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 09/04/2019; 09/04/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 10/30/2019; 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1