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

Catalog Number ZISV6-35-125-6.0-100-PTX

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The patient had a sfa occlusion and dr (b)(6) requested to use the 6x100mm ptx stent.The ptx stent was handed over and opened by dr (b)(6), the stent was prepared by flushing at the back.The ptx stent was inserted over the guide wire and through the introducer sheath, the stent was positioned to the selected area of treatment.Dr (b)(6) released / pushed the red safety button to start deployment.While trying to deploy the stent by using the thumb-wheel on the delivery system , we noticed that the nothing was happening on the angiogram and the stent wasn't deploying, the stent was still inside the sheath.We safely removed the ptx stent through the 45cm sheath and placed it inside a red contaminated hospital bag.I phoned my manager to inform him about the situation and make them aware of the incident.Dr (b)(6) requested another ptx stent and it worked 100%." fda mdr reporting required: event is fda mdr conservatively reportable based on the device malfunction reporting precedence for this device family for the issue of thumbwheel malfunctions during deployment'.No adverse effects to the patient have been reported as occurring.This complaint report does not meet the requirements of an adverse reaction/device defect report as per 21 cfr part 814.82 (a)((9).

Event Description

¿the patient had a sfa occlusion and dr asha malan requested to use the 6x100mm ptx stent.The ptx stent was handed over and opened by dr asha, the stent was prepared by flushing at the back.The ptx stent was inserted over the guide wire and through the introducer sheath, the stent was positioned to the selected area of treatment.Dr asha released / pushed the red safety button to start deployment.While trying to deploy the stent by using the thumb-wheel on the delivery system , we noticed that the nothing was happening on the angiogram and the stent wasn't deploying, the stent was still inside the sheath.We safely removed the ptx stent through the 45cm sheath and placed it inside a red contaminated hospital bag.I phoned my manager to inform him about the situation and make them aware of the incident.Dr asha requested another ptx stent and it worked 100%.¿ fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿retraction wire separates from stent retraction sheath".No adverse effects to the patient have been reported as occurring.This complaint report does not meet the requirements of an adverse reaction/device defect report as per 21 cfr part 814.82 (a)((9).

Manufacturer Narrative

Pma/510(k) #: p100022/s014.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.Device evaluation: the zisv6-35-125-6.0-100-ptx device of lot number c1602786 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 17 october 2019.Refer to attachments (b)(4) for lab attendance and notes.The returned device lab examination findings and observations can be referred through attached photos.On evaluation of the device a kink was observed 35 mm from the distal end of the strain relief.A 0.035¿ wire guide could not pass the kink and the device could not be flushed.The device handle was dismantled during the evaluation and the retraction wire was noted to be separated from the stent retraction sheath (srs).No other damage was observed on the outer sheath.Document review: prior to distribution zisv6-35-125-6.0-100-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 zisv6-35-125-6.0-100-ptx of lot number c1602786 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.During the review of relevant manufacturing records one non-conformance was noted for a defective distal inner (nc code gen-123).It was noted that the flexor tip was not formed correctly.The defective distal inner was scrapped.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1602786.It should be noted that the instructions for use (ifu0117-4) states the following: ¿do not use excessive force to deploy the stent.If excessive resistance is felt when beginning deployment, remove the delivery system without deploying the stent and replace with a new device.¿ there is no evidence to suggest the user did not follow the ifu.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 insufficient device support as a result of ipsilateral approach and/or difficult patient anatomy.From the information provided it is known that the device was advanced via ipsilateral approach and the patient¿s anatomy was calcified.As a result of an ipsilateral approach some of the outer sheath would have remained outside the patient¿s body.It is possible that this resulted in insufficient device support during advancement which may have resulted in the formation of the kink on the outer sheath.It is also possible that the calcified patient anatomy contributed to the formation of the kink.The kink may have prevented retraction of the retraction wire as the user rotated the thumbwheel of the device to begin deployment resulting in increased tension along the wire.This would have resulted in the retraction wire separating from the stent retraction sheath which would have prevented stent deployment.Summary: complaint is confirmed as the failure was verified in the laboratory.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 IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9202940
• MDR Text Key: 220536059
• Report Number: 3001845648-2019-00555
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002352848
• UDI-Public: (01)10827002352848(17)201210(10)C1602786
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2020
• Device Catalogue Number: ZISV6-35-125-6.0-100-PTX
• Device Lot Number: C1602786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/11/2019
• Event Location: Hospital
• Date Manufacturer Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1