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

Catalog Number ZISV6-35-80-7.0-60-PTX

Device Problems Fracture (1260); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

Pma #p100022/s014.(b)(4).(b)(6).Investigation pending, a follow up mdr will be submitted with the investigation conclusions.

Event Description

Initial mdr is being submitted based on the device malfunction precedence: ¿thumbwheel malfunctions during deployment".There was a zilver ptx stent not deploying."as per complaint form": while deploying the stent, halfway through it did not go further.The tumble wheel kept going but noting was moving anymore.The doctor pulled the sheath back and the stent was left behind in the vessel.

Manufacturer Narrative

Pma #(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).Investigation pending, a follow up mdr will be submitted with the investigation conclusions.

Event Description

Mdr is being submitted based on the device malfunction precedence: ¿thumbwheel malfunctions during deployment" and "retraction wire separates from stent retraction sheath" there was a zilver ptx stent not deploying."as per complaint form": while deploying the stent, halfway through it did not go further.The tumble wheel kept going but noting was moving anymore.The doctor pulled the sheath back and the stent was left behind in the vessel.

Manufacturer Narrative

Pma #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) (b)(4).Importer site establishment registration number: (b)(4).Problem statement: "there was a zilver ptx stent not deploying."as per complaint form": while deploying the stent, halfway through it did not go further.The tumble wheel kept going but noting was moving anymore.The doctor pulled the sheath back and the stent was left behind in the vessel." from customer testimony it is known that the target location was the superficial femoral artery.The patient did not require any additional procedures as a result of this event.Three attempts have been made to obtain further information regarding this complaint.No answers have been received to date.Device evaluation: the zisv6-35-80-7.0-60-ptx device of lot number c1478005 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.The device related to this occurrence underwent a laboratory evaluation on the 23 july 2018.On evaluation of the returned device, a kink was observed 23.7cm from the end of the stent retraction sheath (srs) and there was a shape set on the stability sheath (ss) and the srs.The device flushed with no issues despite the inability to advance a 0.035¿ wire guide through the kink in the srs.The thumbwheel rotated freely.The device was returned with the red safety trigger engaged and without the stent.The device was opened and congealed blood was found contained within the system.The retraction wire was found separated from the srs.The customer¿s testimony could not be confirmed as there is no evidence to suggest the stent did not deploy.However, the complaint is confirmed based on the failure verified in the investigation.The retraction wire was found separated from the srs.It is possible that this caused or contributed to difficulty during deployment.Possible root causes for this investigation could include difficult patient anatomy.It is possible that the patient¿s anatomy was difficult causing or contributing to resistance during advancement and/or deployment.Resistance during advancement and/or deployment could have caused or contributed to the separation of the retraction wire from the srs resulting in the stent not fully deploying through use of the thumbwheel mechanism.Congealed blood around the retraction wire could have contributed to resistance during deployment contributing to separation of the srs.Resistance during advancement and/or withdrawal could cause or contribute to the kink and a shape set observed on the srs and ss during the lab evaluation.However, as extra information was not provided and as the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.Instructions for use states; ¿if resistance is met during advancement of the delivery system, do not force passage.Remove the delivery system and replace with a new device.¿ ¿do not use excessive force to deploy the stent.If excessive force is felt when beginning deployment, remove the delivery system without deploying the stent and replace with a new device.¿ it may be noted that a capa has been initiated to document and track the actions taken to investigate the stent retraction wire/stent retraction sheath joint separation.Document review: the zisv6-35-80-7.0-60-ptx device of lot number c1478005 contains zvsp6-t-35-80-7.0-60-is of lot number ch1464532.Prior to distribution all zisv6 devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records 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 c1478005.Summary: the customer¿s testimony could not be confirmed as there is no evidence to suggest the stent did not deploy.However, the complaint is confirmed based on the failure verified in the investigation.The retraction wire was found separated from the srs.It is possible that this caused or contributed to difficulty during deployment.The risk was determined to be low (category iii).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

Mdr is being submitted based on the device malfunction precedence: ¿thumbwheel malfunctions during deployment" and "retraction wire separates from stent retraction sheath".There was a zilver ptx stent not deploying."as per complaint form": while deploying the stent, halfway through it did not go further.The tumble wheel kept going but noting was moving anymore.The doctor pulled the sheath back and the stent was left behind in the vessel.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7672924
• MDR Text Key: 113507738
• Report Number: 3001845648-2018-00313
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002353135
• UDI-Public: (01)10827002353135(17)200321(10)C1478005
• 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,Followup
• Report Date: 08/07/2018

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: 03/21/2020
• Device Catalogue Number: ZISV6-35-80-7.0-60-PTX
• Device Lot Number: C1478005
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/09/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/12/2018
• Initial Date FDA Received: 07/10/2018
• Supplement Dates Manufacturer Received: 06/12/2018; 06/12/2018
• Supplement Dates FDA Received: 08/07/2018; 09/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1