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

Catalog Number ZISV6-35-125-6-120-PTX

Device Problems Stretched (1601); Delivery System Failure (2905); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: p050017/s002 and s003.(b)(4).Problem statement as reported to customer relations: "device quit deploying.They were able to finish deploying it, but it elongated".Device evaluation the zisv6-35-125-6-120-ptx device of unknown lot number involved in this complaint has not yet been returned for evaluation.With the information provided, a document based investigation was conducted.The customer was contacted to return the complaint device.The investigation will be updated once the device has been returned and evaluated.From customer testimony, it is known that physician had difficulties with the thumbwheel deployment mechanism.The procedure was completed by pulling the delivery system, and the stent was deployed fully, however the stent was elongated as a result.No portion of the device broke off in the patient.The patient did not require any additional intervention as a result of this occurrence, and there was no harm to patient.The complaint device was advanced over a 0.035¿ diameter amplatz wire guide.The device was flushed prior to the procedure.It is unknown if the patient¿s anatomy was calcified or tortuous.Pre-dilation was conducted prior to stent deployment.There is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.Possible causes for this occurrence could include a difficult patient anatomy.If the patient¿s anatomy was severely calcified or tortuous, it could create resistance during deployment.Such resistance could have caused or contributed to the malfunction of the thumbwheel deployment mechanism.However, as the device has not yet been returned, and the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.There is no evidence to suggest that the customer did not follow the instructions for use.Document review as the lot number of the complaint device is unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity as per fqc.It may be noted that the failure mode of "deployment difficult" has been provisionally assigned.The final failure mode will be confirmed following device return and evaluation.Summary there is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.The risk will be assessed for this complaint once the device has been returned and evaluated, and once completed the investigation will be updated with the risk details.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The stent was fully deployed, but elongated.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Initial mdr is being submitted based on the device malfunction precedence: ¿thumbwheel malfunctions during deployment" and "stent elongation".As reported to customer relations: "device quit deploying.They were able to finish deploying it, but it elongated.".

Event Description

This follow up mdr is being submitted.Initial mdr submitted based on the device malfunction precedence: ¿thumbwheel malfunctions during deployment" and "stent elongation" as reported to customer relations: "device quit deploying.They were able to finish deploying it, but it elongated.".

Manufacturer Narrative

Pma/510(k) # p050017/s002 and s003.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).Problem statement as reported to customer relations: "device quit deploying.They were able to finish deploying it, but it elongated." from customer testimony, it is known that physician had difficulties with the thumbwheel deployment mechanism.The procedure was completed by pulling the delivery system, and the stent was deployed fully, however the stent was elongated as a result.No portion of the device broke off in the patient.The patient did not require any additional intervention as a result of this occurrence, and there was no harm to patient.The complaint device was advanced over a 0.035¿ diameter amplatz wire guide.The device was flushed prior to the procedure.It is unknown if the patient¿s anatomy was calcified or tortuous.Pre-dilation was conducted prior to stent deployment the customer was contacted to request additional information about the patient anatomy, but was unable to recall the details of the case.Device evaluation: the zisv6-35-125-6-120-ptx device of lot number c1461800 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 31st may 2018.On evaluation of the returned device, it was observed that the device was returned with protective tubing.The distal white tip was withdrawn into the distal end of the stent retraction sheath (srs) by 2.5cm.The device was returned with the safety trigger depressed.There was tactile damage and crinkles found on the srs.The srs was found to be elongated, as the distance between the stain relief and the distal end of the srs measured as 127.2cm, which is within specification of 125.0cm +1/-2cm.The device was flushed without any issues, and a 0.035¿ diameter wire guide could pass through the device without resistance.The device handle was opened, and the stent retraction wire was found to be separated from the stent retraction sheath.The proximal inner was damaged at the first laser cut.The stent retraction wire separation likely caused the white tip to be withdrawn into the srs, as the srs was no longer attached to the stent retraction wire and could move freely.The distal white tip was released from the srs, and confirmed to be intact.There were crinkles observed, between 20 and 30cm from the distal end of the srs.Complaint is confirmed as the failure was verified in the laboratory.The stent retraction wire was found to be separated from the stent retraction sheath.Root cause: possible causes for this occurrence could include a difficult patient anatomy.If the patient¿s anatomy was severely calcified or tortuous, it could create resistance during deployment.Such resistance could have caused or contributed to the stent retraction wire separating from the stent retraction sheath.However, as the information about the patient¿s anatomy was not available, and the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.There is no evidence to suggest that the customer did not follow the instructions for use.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 zisv6-35-125-6-120-ptx device of lot number c1461800 contains zvsp6-t-35-125-6-120-is (zilver ptx) of lot ch1426086.Prior to distribution all zilver ptx 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 c1461800.Summary complaint is confirmed as the failure was verified in the laboratory.The stent retraction wire was found to be separated from the stent retraction sheath.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.The stent was fully deployed, but elongated.

Manufacturer Narrative

Pma/510(k) # p050017/s002 and s003.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).Investigation pending, a follow up mdr will be submitted with the investigation conclusions.

Event Description

This follow up mdr is being submitted to inform the fda that the device has been returned and the investigation is in progress.A follow up report will be sent within 30 days.Initial mdr submitted based on the device malfunction precedence: ¿thumbwheel malfunctions during deployment" and "stent elongation." as reported to customer relations: "device quit deploying.They were able to finish deploying it, but it elongated.".

• 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; national technology park; limerick
• MDR Report Key: 7502681
• MDR Text Key: 108387933
• Report Number: 3001845648-2018-00208
• Device Sequence Number: 1
• Product Code: NIU
• 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: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-6-120-PTX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/13/2018
• Event Location: Hospital
• Date Manufacturer Received: 04/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1