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 Break (1069); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2018

Event Type  Injury  

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.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This event meets the criteria of an fda ¿serious injury¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ section 2.13 and 2.15.Also reportable under precedence's: stent fracture, thumbwheel malfunctions during deployment and retraction wire separates from stent retraction sheath.As reported to customer relations: "first device (7x120) was deployed successfully.Second device (7x120) didn't deploy correctly, and the 2nd stent broke trying to remove the delivery device.The distal portion that broke was left in the patient's sfa and ballooned against the arterial walls.Everything else was attached to the delivery device and was removed successfully.A third device (7x100, as they didn't have any 7x120s left) was used successfully to complete".Per dm: "started to deploy (2nd device), thumbwheel kept spinning but wouldn't deploy any further.Wire inside broke, couldn't do "pin and pull", physician tried to retrieve everything and that's when the distal portion broke off".

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)(4).Cook medical incorporated (cmi), 1025 acuff road, p.O box 4195, bloomington , indiana 47402-4195.Importer site establishment registration number: 3005580113.Device evaluation: the zisv6-35-125-7-120-ptx device of lot number c1425219 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.A 6x55 ansel sheath and a 0.018¿ boston scientific v18 wire guide were used with this device.Pre-dilation and post-dilation were performed before and after placement of the stent.The device was flushed as per the instructions for use (ifu).The patient¿s anatomy was described as mildly tortuous and moderately calcified.The target location for the complaint device was the superficial femoral artery (sfa).A contralateral approach was taken to access the target location.The bifurcation angle was described as normal.The stent crossed the target location and started to deploy but the thumbwheel kept spinning and the stent would not deploy any further.Approximately 30.0 mm of the distal portion of device remained inside the patient despite the physician¿s attempt to retrieve everything.The device related to this occurrence underwent a laboratory evaluation on the 30 august 2018.On evaluation of the returned device, the distal white tip was severely damaged, the proximal inner was broken and a kink was observed in the centre stent nesting area.There was significant damage on the flexor at the point of entry into the hub.A significant kink was observed at 51.2 mm from the distal end of the stability sheath (ss) overmold and 80.0 mm from the distal end of the overmold.Approximately 90.0 mm of the stent was returned in the delivery system with approximately 30.0 mm not returned and the proximal inner was broken.The stent retraction sheath (srs) could not be moved independently within the ss and the stent could not be deployed in the lab (potentially due to congealed blood).The distal inner was pulled to release the stent (90.0mm).Once released from the delivery system the stent was measured and was 95.0 mm in length.Complaint is confirmed as the failure was verified in the laboratory.Approximately 30.0 mm of the stent was not returned with the device and the retraction wire was separated.Possible root causes for this complaint could include difficult patient anatomy, incorrect device handling and/or the use of a non-recommended wire guide.The use of a non-recommended wire guide could have resulted in insufficient support for the device during advancement and/or deployment.Insufficient device support could have caused or contributed to retraction wire separation resulting in the separation of the partially deployed portion (approx.30.0 mm) of the stent.The damage observed on the flexor and tip of the device is indicative of difficult patient anatomy.Difficult patient anatomy could have caused or contributed to some resistance during advancement and/or deployment.The resistance could have caused or contributed to the retraction wire breaking during deployment preventing complete deployment of the stent.Incorrect device handling during removal from the packaging and/or device preparation may have damaged the proximal inner at the first spiral cut.This damage could have resulted in the retraction wire failure.However, as the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.The instructions for use (ifu0118-3) states the following; ¿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.¿ ¿if resistance is met during advancement of the delivery system, do not force passage.Remove the delivery system and replace with a new device.¿ it may be noted that a capa has been initiated to address the issue of retraction wire separation.Document review: 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 c1425219.Summary: there is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.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

This event is being reported as it meets the criteria of an fda ¿serious injury¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ section 2.13 and 2.15.Also reportable under precedences: stent fracture, thumbwheel malfunctions during deployment and retraction wire separates from stent retraction sheath.Following the device evaluation the following fda mdr malfunction precedence's are also applicable: delivery system cannot be withdrawn and deployment difficulty resulting in partial stent deployment.As reported to customer relations: "first device (7x120) was deployed successfully.Second device (7x120) didn't deploy correctly, and the 2nd stent broke trying to remove the delivery device.The distal portion that broke was left in the patient's sfa and ballooned against the arterial walls.Everything else was attached to the delivery device and was removed successfully.A third device (7x100, as they didn't have any 7x120s left) was used successfully to complete." per dm: "started to deploy (2nd device), thumbwheel kept spinning but wouldn't deploy any further.Wire inside broke, couldn't do "pin and pull", physician tried to retrieve everything and that's when the distal portion broke off.".

• 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: 7801597
• MDR Text Key: 117747914
• Report Number: 3001845648-2018-00391
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384900
• UDI-Public: (01)10827002384900(17)191005(10)C1425219
• 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: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2019
• Device Model Number: G38490
• Device Catalogue Number: ZISV6-35-125-7-120-PTX
• Device Lot Number: C1425219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/24/2018
• Event Location: Hospital
• Date Manufacturer Received: 07/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR