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

Model Number	G38489
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #= p100022/s014.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, "contralateral access through 6 f sheath.Stent prepped according to ifu.Loaded and advanced on.018 wire (doesn¿t remember which one).No issues with getting stent delivery system in place.Pressed red button to unlock, heard audible click.Stent started to open out of delivery system but stopped.Kept rolling and wouldn¿t come out of delivery system.Had to remove from out of body and put new stent in, which worked fine.No harm to patient or additional procedures required.Have stent to send back- please issue rga.".
Additional Manufacturer Narrative
Pma/510(k) #= p100022/s014.(b)(4).Exemption number: e2016031 information pertaining to manufacturer as follows: importer site contact and address: (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
As reported to customer relations, "contralateral access through 6 f sheath.Stent prepped according to ifu.Loaded and advanced on.018 wire (doesn¿t remember which one).No issues with getting stent delivery system in place.Pressed red button to unlock, heard audible click.Stent started to open out of delivery system but stopped.Kept rolling and wouldn¿t come out of delivery system.Had to remove from out of body and put new stent in, which worked fine.No harm to patient or additional procedures required.Have stent to send back- please issue rga.".
Additional Manufacturer Narrative
Pma/510(k) #= (b)(4).Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(4).Importer site establishment registration number: (b)(4).Device evaluation the zisv6-35-125-7-100-ptx device of lot number c1542072 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.Lab evaluation the device related to this occurrence underwent a laboratory evaluation on the 13 december 2018.The returned device lab examination findings and observations can be referred through attached photos.During the evaluation, it was observed that the retraction wire had separated from the stent retraction sheath (srs) which would have immobilised the stent deployment mechanism.Document review prior to distribution zisv6-35-125-7-100-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 zisv6-35-125-7-100-ptx of lot number c1542072 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 c1542072.It may be noted that the instructions for use states the following: ¿a 0.035 inch (0.89mm) diameter wire guide should be used during tracking, deployment, and removal in order to ensure adequate support of the system.If hydrophilic wire guides are used, they must be kept fully activated.¿ 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 the use of a non-recommended wire guide.The use of a non-recommended wire guide could have caused and/or contributed to inadequate device support during advancement and/or attempted deployment.It is possible that inadequate device support could have resulted in additional force on the flexor and instability resulting in separation of the retraction wire from the srs and consequently, failed deployment.Summary complaint is confirmed as the failure was verified in the laboratory.The retraction wire was separated from the srs possibly as a result of the use of a non-recommended wire guide with the device.This would have caused and/or contributed to failed deployment.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, "contralateral access through 6 f sheath.Stent prepped according to ifu.Loaded and advanced on.018 wire (doesn¿t remember which one).No issues with getting stent delivery system in place.Pressed red button to unlock, heard audible click.Stent started to open out of delivery system but stopped.Kept rolling and wouldn¿t come out of delivery system.Had to remove from out of body and put new stent in, which worked fine.No harm to patient or additional procedures required.Have stent to send back- please issue rga.".

• 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: 8098808
• Report Number: 3001845648-2018-00543
• Device Sequence Number: 2165750
• Product Code: NIU
• UDI-Device Identifier: 10827002384894
• UDI-Public: (01)10827002384894(17)200404(10)C1542072
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2018

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: 04/04/2020
• Device Model Number: G38489
• Device Catalogue Number: ZISV6-35-125-7-100-PTX
• Device Lot Number: C1542072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/25/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 10/29/2018; 10/29/2018
• Initial Report FDA Received Date: 11/22/2018
• Supplement Report FDA Received Date: 12/20/2018; 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1