MAUDE Adverse Event Report: COOK INC ZILVER PTX DRUG-ELUTING PERIPHERAL STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Catalog Number ZISV6-35-125-7.0-120-PTX

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: p100022/s014.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

The delivery system was advanced from the femoral artery.The physician initiated stent deployment by rotating the device thumbwheel.However, he was unable to deploy the stent.He substituted another cook delivery system (ptx7.0-140) to complete the procedure.

Event Description

The delivery system was advanced from the femoral artery.The physician initiated stent deployment by rotating the device thumbwheel.However, he was unable to deploy the stent.He substituted another cook delivery system (ptx7.0-140) to complete the procedure.

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)(6), cook medical incorporated (cmi) 1025 acuff road, p.O box 4195, bloomington, indiana 47402-4195.Importer site establishment registration number: (b)(4).Device evaluation: the zisv6-35-125-7.0-120-ptx device of lot number c1432996 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 13 december 2018.The returned device lab examination findings and observations can be referred through attached photos.The retraction wire was observed to be separated from the stent retraction sheath (srs).The stent was fractured as the delivery system was withdrawn from the patient as a result of incomplete deployment due to retraction wire separation.Document review: prior to distribution zisv6-35-125-7.0-120-ptx devices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 zisv6-35-125-7.0-120-ptx of lot number c1432996 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 c1432996.It should be noted that the packaging insert states the following: method of usage: preparation of the stent to ensure adequate support of the system, introduce a 0.89mm (0.035 inch) guide wire through the sheath across the distal segment if the target lesion.Note: if hydrophilic guide wires are used, they must be kept fully activated.¿ it should be noted that the instructions for use states the following: ¿precautions a 0.89mm (0.035 inch) wire guide should be used during tracking, deployment, and removal 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 of retraction wire separation was identified in the laboratory.This can be attributed to the user error situation whereby a non-recommended wire guide was used with the device.From the information provided, a 0.014¿ wire guide was used to advance the device through the patient¿s tortuous and calcified anatomy.This would have resulted in insufficient device support during advancement and attempted deployment causing and/or contributing to the separation of the retraction wire from the srs and the inability to deploy the stent.Summary: complaint is confirmed as the failure was verified in the laboratory.The retraction wire was separated from the stent retraction sheath (srs) which would have prevented stent 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.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8183483
• MDR Text Key: 131597291
• Report Number: 3001845648-2018-00609
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002352909
• UDI-Public: (01)10827002352909(17)191117(10)C1432996
• 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: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2019
• Device Catalogue Number: ZISV6-35-125-7.0-120-PTX
• Device Lot Number: C1432996
• 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: 12/20/2018
• Event Location: Hospital
• Date Manufacturer Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1