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

Model Number G38490

Device Problems Fracture (1260); Delivery System Failure (2905)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k) #p100022/s014.The zisv6-35-125-7-120-ptx device of lot number c1398641 involved in this complaint has not yet been returned for evaluation.With the information provided, a document based investigation was conducted.The customer has confirmed that the complaint device is en route.The investigation will be updated once the device has been returned and evaluated.From customer testimony, it is known that the complaint device was advanced over an abbot spartacore 300 wire guide, but the customer does not recall the diameter of the wire guide.The customer also stated that the complaint device was advanced through the previously placed stents.The complaint device did not encounter resistance during advancement.It is also known that the device was flushed prior to use.The stent was partially deployed.The patient anatomy was not severely 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 placing the complaint device distally to the previously placed stents, which could cause or contribute to the resistance encountered during deployment.The stent was likely fractured as the physician attempted to withdraw the complaint device.However, as the device have not yet been provided, and the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.It can be noted that as per the product instruction for use: "in relation to the lesion site, the distal area of the narrowing should be stented first, followed by the proximal locations (i.E., a second stent should by placed proximally to the previously placed stent)." 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 c1398641.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The physician deployed another stent in the fractured stent portion.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

There were 5 previous stents placed in left leg from iliac to sfa.We were deploying the last device and the thumbwheel stopped deploying half way through the stent deployment.We took the handle apart and tried to finish deployment but was unsuccessful.Physician pulled delivery device and deployed some more but broke in two.Part of the stent stayed in the delivery system and was pulled out.They used another of the same device, rewired it, and successfully deployed inside of the partially deployed stent.Access was left brachial approach.

Manufacturer Narrative

(b)(4).Exemption number: e2016031.(b)(4).Pma/510(k) #p100022/s014.This follow up mdr is being submitted due to device return.The evaluation is being carried out and a follow up report containing the investigation details will be submitted within 30 days.

Event Description

This follow up mdr is being submitted due to device return.The evaluation is being carried out and a follow up report containing the investigation details will be submitted within 30 days.There were 5 previous stents placed in left leg from ilicac to sfa.We were deploying the last device and the thumbwheel stopped deploying half way through the stent deployment.We took the handle apart and tried to finish deployment but was unsuccessful.Physician pulled delivery device and deployed some more but broke in two.Part of the stent stayed in the delivery system and was pulled out.They used another of the same device, rewired it, and successfully deployed inside of the partially deployed stent.Access was left brachial approach.

Manufacturer Narrative

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: (b)(4).Pma/510(k)#: p100022/s014.Device evaluation: the zisv6-35-125-7-120-ptx device of lot number: c1398641 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.From customer testimony, it is known that the complaint device was advanced over an abbot spartacore 300 wire guide.The customer also stated that the complaint device was advanced through the previously placed stents.The complaint device did not encounter resistance during advancement.It is also known that the device was flushed prior to use.The stent was partially deployed.The patient anatomy was not severely calcified or tortuous.Pre-dilation was conducted prior to stent deployment.A review of the abbot product catalogue shows that the spartacore 300 wire guides are only available in 0.014¿ diameter.The device related to this occurrence underwent a laboratory evaluation on the 15th february 2018.On evaluation of the returned device, it was observed that the device was returned disassembled, and the stent was partially deployed.The stent retraction wire was found to be separated from the stent retraction sheath (srs).A kink was observed, 14.6cm from the distal end of the srs.There was rippling damage 25.5cm from the distal end of the srs.Damage was noted on the proximal end of the stability sheath (ss), just past the strain relief.The stent length was 11.3cm, and there was evidence of stent fracture.The proximal inner component was damage at the first and second laser cuts.A 0.035¿ diameter wire guide was passed through the device without issue.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 (srs).Possible causes for this occurrence could include the use of the device with a non-recommended wire guide.From customer testimony, the device was used with a spartacore 300 wire guide, which is only available in a 0.014¿ diameter.The wire guide could have provided insufficient support during advancement and deployment, causing the damage on the srs and the proximal inner.The damage could cause or contribute to the resistance encountered during deployment, and caused the retraction wire to separate from the stent retraction sheath (srs).The stent was likely fractured as the physician attempted to withdraw the complaint device after the stent was partially deployed.However, as the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.It can be noted that as per the product instruction for use: precautions: ¿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¿ "in relation to the lesion site, the distal area of the narrowing should be stented first, followed by the proximal locations (i.E., a second stent should by placed proximally to the previously placed stent)." a capa: ((b)(4)) has been initiated to document and track the actions taken to investigate the stent retraction wire/stent retraction sheath joint separation.Document review: prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity as per fqc.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: c1398641.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 (srs).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 physician deployed another stent in the fractured stent portion.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This follow up mdr is being submitted due to device return.The investigation has been updated with the evaluation results.There were 5 previous stents placed in left leg from ilicac to sfa.We were deploying the last device and the thumbwheel stopped deploying half way through the stent deployment.We took the handle apart and tried to finish deployment but was unsuccessful.Physician pulled delivery device and deployed some more but broke in two.Part of the stent stayed in the delivery system and was pulled out.They used another of the same device, rewired it, and successfully deployed inside of the partially deployed stent.Access was left brachial approach.

• 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: 7265988
• MDR Text Key: 100128854
• Report Number: 3001845648-2018-00051
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384900
• UDI-Public: (01)10827002384900(17)190725(10)C1398641
• 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: 03/15/2018

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: No Information
• Device Model Number: G38490
• Device Catalogue Number: ZISV6-35-125-7-120-PTX
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/16/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/16/2018
• Initial Date FDA Received: 02/13/2018
• Supplement Dates Manufacturer Received: 02/15/2018; 03/15/2018
• Supplement Dates FDA Received: 03/15/2018; 04/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 136