MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number	G38483
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # = p100022/s026.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
As reported to customer relations "the wire was in.It had crossed the lesion.As they were advancing the stent over the wire, the stent was sticking.The wire guide was a cordis aquatrack glide wire.When they went to remove the stent off the wire, the wire was stuck in the stent.They could not remove the stent from the wire.They had to pull the stent and wire from the patient.They successfully completed the procedure with a new wire and stent.".
Additional Manufacturer Narrative
Pma/510(k) # = p100022/s026.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 zisv6-35-125-6-140-ptx device of lot number c1525769 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 25th april 2019.The wire guide from the procedure was stuck inside the device on return.A kink was observed on the distal end of the stability sheath (ss) and crinkling was observed on the stent retraction sheath (srs) distal to the kink.Document review including ifu review: prior to distribution zisv6-35-125-6-140-ptx 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 manufacturing records for zisv6-35-125-6-140-ptx of lot number c1525769 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current 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 c1525769.There is no evidence to suggest that the customer did not follow the instructions for use.However, it should be noted that the ifu states the following: ¿if resistance is met during advancement of the delivery system, do not force passage.Remove the delivery system and replace with a new device.¿ image review ¿ n/a.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 could be attributed to difficult patient anatomy.It is possible that a difficult patient anatomy could have caused and/or contributed to the crinkling observed on the sheath and resistance during advancement.It is possible that this resistance caused a kink to form preventing removal of the wire guide and stent deployment.Summary: complaint is confirmed as the failure was verified in the laboratory.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
As reported to customer relations "the wire was in.It had crossed the lesion.As they were advancing the stent over the wire, the stent was sticking.The wire guide was a cordis aquatrack glide wire.When they went to remove the stent off the wire, the wire was stuck in the stent.They could not remove the stent from the wire.They had to pull the stent and wire from the patient.They successfully completed the procedure with a new wire and stent.".

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Common Device Name: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8548219
• Report Number: 3001845648-2019-00172
• Device Sequence Number: 16233477
• Product Code: NIU
• UDI-Device Identifier: 10827002384832
• UDI-Public: (01)10827002384832(17)200420(10)C1525769
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/25/2019

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: 04/20/2020
• Device Model Number: G38483
• Device Catalogue Number: ZISV6-35-125-6-140-PTX
• Device Lot Number: C1525769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1