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

Model Number G38481

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 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 reporting precedence for this device family for the issue of ¿thumbwheel malfunctions during deployment", ¿deployment difficulty resulting in partial stent deployment¿ and "stent elongation".As reported to customer relations: "procedure was an arteriogram.Very calcified sfa.The 6x100 ptx crossed but the thumbwheel broke.Physician pulled the system back which released the stent but stretched to double the length.They then put a cover stent in.No adverse event to patient.

Event Description

Report is being submitted based on the device malfunction reporting precedence for this device family for the issue of ¿thumbwheel malfunctions during deployment", ¿deployment difficulty resulting in partial stent deployment¿, "retraction wire separated from the stent retraction sheath" and "stent elongation".As reported to customer relations: "procedure was an arteriogram.Very calcified sfa.The 6x100 ptx crossed but the thumbwheel broke.Physician pulled the system back which released the stent but stretched to double the length.They then put a cover stent in.No adverse event to patient." additional information provided by dm on 14aug2018: "was the second stent placed to treat the elongated zilver stent? they used a covered stent to treat the elongated ptx.".

Manufacturer Narrative

510(k) number: p100022/s014.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to mfr site as follows: importer site contact and address: (b)(6).(b)(4).Problem statement: " as reported to customer relations: "procedure was an arteriogram.Very calcified sfa.The 6x100 ptx crossed but the thumbwheel broke.Physician pulled the system back which released the stent but stretched to double the length.They then put a cover stent in.No adverse event to patient." additional information provided by dm on 14aug2018: "was the second stent placed to treat the elongated zilver stent? they used a covered stent to treat the elongated ptx.".Device evaluation: the zisv6-35-125-6-100-ptx device of lot number: c1400261 involved in this complaint was returned for evaluation, without the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document based investigation was conducted.From customer testimony a contralateral approach was used to advance the device to the superficial femoral artery (sfa).The angle of bifurcation was described as tight and calcified.Pre and post dilation was performed before and after placement of the stent.A long glidewire of unknown diameter was used with the device.A 5ft galt access sheath was exchanged for a 6fr x 45cm ansel sheath.The device was flushed as per the instructions for use (ifu).Resistance was not encountered during advancement of the wire guide or the delivery system.It was confirmed that the stent delivery system crossed the target location.A covered stent was used to treat the elongated ptx stent.The device related to this occurrence underwent a laboratory evaluation on the 23 july 2018.On evaluation of the returned device, there was excessive crinkling on the stent retraction sheath (srs)/stability sheath (ss).A kink was noted just distal to the strain relief.The retraction wire was separated from the srs.It was not possible to flush the device past the kink in the distal strain relief.A 0.035¿ wire guide could not be advanced through the device.The device was returned without the stent and the red safety trigger was depressed.There was no damage on the white tip (ref att.'images').Images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer (ref: (b)(4) imaging review ver 1'): is the complaint confirmed? no.Inability to completely un-sheath the stent cannot be confirmed because imaging of the complaint was not provided.Observation of device effects, relative to the patient's anatomy: a high and acutely angulated aortic bifurcation was confirmed.This would have increased the retraction force required to pull back the retraction sheath.Observation of device effects, relative to the disease state: none.Observation of significant findings relative to the use of the device: none.Observation of additional device findings relative to the clinical perspective: none.Other (as requested in complaint review intake form): none.Findings: 1.A single angiographic image from an abdominal aortogram photographed off an angiography monitor is provided along with the complaint report.2.The image demonstrates a high, acutely angulated aortic bifurcation.The radius of the arc between the common iliac arteries was approximately 8mm.The angle subtended by this arc was 37 degrees.Accordingly, the common iliac arteries were unusually long.3.A diagnostic catheter had been advanced retrograde into the aorta from the right.Presumably the left sfa was the target.Impression: inability to completely un-sheath the stent cannot be confirmed because imaging of the complaint was not provided.The high, acutely angulated aortic bifurcation would have increased the force required to retract the sheath.Complaint is confirmed as the failure was verified in the laboratory.The stent retraction wire was separated from the stent retraction sheath.As per the imaging review, a root cause for this complaint could include difficult patient anatomy.It is possible that the calcified, tortuous bifurcation around which the device was advanced, caused or contributed to some resistance during advancement and/or deployment.As per the imaging review ¿the high, acutely angulated aortic bifurcation would have increased the force required to retract the sheath¿.It is likely that resistance during advancement and/or deployment along with the force required to retract the sheath could have caused or contributed to the retraction wire separation.Resistance during advancement and/or withdrawal of the device due to difficult anatomy and a tight bifurcation angle could have caused or contributed to crinkles forming on the srs.However, as 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.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 zisv6-35-125-6-100-ptx device of lot number: c1400261 contains zvsp6-t-35-125-6-100-is of lot number: ch1378894.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 (c1400261 and ch1378894) 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: c1400261.Summary: complaint is confirmed as the failure was verified in the laboratory.The stent retraction wire was separated from the stent retraction sheath.The risk was determined to be low (category iii).According to the initial reporter, the patient required a second covered stent to treat the elongated ptx.Complaints of this nature will continue to be monitored for potential emerging trends.

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 (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 reporting precedence for this device family for the issue of ¿thumbwheel malfunctions during deployment", ¿deployment difficulty resulting in partial stent deployment¿ and "stent elongation".As reported to customer relations: "procedure was an arteriogram.Very calcified sfa.The 6x100 ptx crossed but the thumbwheel broke.Physician pulled the system back which released the stent but stretched to double the length.They then put a cover stent in.No adverse event to patient.

• 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: 7663588
• MDR Text Key: 113515062
• Report Number: 3001845648-2018-00306
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384818
• UDI-Public: (01)10827002384818(17)190720(10)C1400261
• 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: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2019
• Device Model Number: G38481
• Device Catalogue Number: ZISV6-35-125-6-100-PTX
• Device Lot Number: C1400261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/08/2018
• Event Location: Hospital
• Date Manufacturer Received: 06/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 67