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

Model Number G38483

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # = p100022/s026.(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 Description

As initially reported to customer relations: a (b)(6) patient of unknown gender underwent an endovascular lower extremity in the sfa right leg which the zilver ptx 35 drug- eluting stent, (b)(4), was used.Also being used was a csi viper wire.014 platform.The bifurcation was very steep and had bilateral common iliac stents.The physician was advancing through 6fr 45 terumo sheath over viper wire and the ptx would not advance to the distal lesion.The wire got stuck in the ptx while taking it out.The physician removed both the ptx and the wire.Glidewire advantage.035 wire was but back down with another stent of the same size with no complications.The physician was also able to deploy another stent, 6x60.There was no harm to the patient and no additional procedures required due to this occurrence.The physician has performed several of these procedures and stated it seemed like this wire was kinked and causing it not to advance or able to be removed.

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 c1543267 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.A kink was identified on the distal end of the delivery system during the lab evaluation and as a result, the wire guide could not be removed from the device.Document 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 c1543267 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 c1543267.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.It is possible that the use of a non-recommended wire guide resulted in insufficient device support during advancement.It is possible that the lack of support caused and/or contributed to the formation of a kink at the distal end of the delivery system.Summary: complaint is confirmed as the failure was verified in the laboratory.A kink was observed at the distal end of the delivery system which would have resulted in the inability to advance the device further.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 Description

As initially reported to customer relations: a 62 year old patient of unknown gender underwent an endovascular lower extremity in the sfa right leg which the zilver ptx 35 drug- eluting stent, g38483, was used.Also being used was a csi viper wire.014 platform.The bifurcation was very steep and had bilateral common iliac stents.The physician was advancing through 6fr 45 terumo sheath over viper wire and the ptx would not advance to the distal lesion.The wire got stuck in the ptx while taking it out.The physician removed both the ptx and the wire.Glidewire advantage.035 wire was but back down with another stent of the same size with no complications.The physician was also able to deploy another stent, 6x60.There was no harm to the patient and no additional procedures required due to this occurrence.The physician has performed several of these procedures and stated it seemed like this wire was kinked and causing it not to advance or able to be removed.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8105196
• MDR Text Key: 129346673
• Report Number: 3001845648-2018-00552
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384832
• UDI-Public: (01)10827002384832(17)190823(10)C1543267
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/27/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2019
• Device Model Number: G38483
• Device Catalogue Number: ZISV6-35-125-6-140-PTX
• Device Lot Number: C1543267
• 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: 10/30/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/01/2018
• Initial Date FDA Received: 11/27/2018
• Supplement Dates Manufacturer Received: 11/01/2018
• Supplement Dates FDA Received: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR