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

Catalog Number ZISV6-35-80-6.0-40-PTX

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).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 precedence: ¿thumbwheel malfunctions during deployment", "retraction wire separates from stent retraction sheath" and "stent shortening/compression during deployment".There was a problem with the device.Not other information received "as per complaint form": puncture of the femoral artery on a wire placement of a 6 fr introducer.Pre dilatation a pta5 35 80 5 4.0 control and a need to placed a stent on the wire placement of the stent without problem starts to deploy the stent and after 2 cm impossible to continue to deploy the stent and the stent compressed on him self continue to deploy but the stent don't deploy correctly( invagination on him self) doctor think that the wire was blocked in a struck of the stent.He takes a.014 wires and placed in the stent without problem and the stent was free from the.035 wire also problem to retrieve the deployment system.The doctor decide to leave the.014 wire in place and cut the.035 and retrieve the system with a piece of wire in the system.On the.014 placed a catheter change for a.035 wire make a post dilatation in the stent and deployed correctly.No problem with the patient.

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 to section g.1 as follows: importer site contact and address: (b)(6).(b)(4).Importer site establishment registration number: (b)(4).Problem statement "there was a problem with the device.Not other information received."as per complaint form": puncture of the femoral artery on a wire placement of a 6 fr introducer.Pre dilatation a pta5 35 80 5 4.0 control and a need to placed a stent on the wire placement of the stent without problem starts to deploy the stent and after 2 cm impossible to continue to deploy the stent and the stent compressed on him self continue to deploy but the stent don't deploy correctly( invagination on him self) doctor think that the wire was blocked in a struck of the stent he takes a.014 wires and placed in the stent without problem and the stent was free from the.035 wire.Also problem to retrieve the deployment system.The doctor decide to leave the.014 wire in place and cut the.035 and retrieve the system with a piece of wire in the system on the.014 placed a catheter change for a.035 wire make a post dilatation in the stent and deployed correctly.No problem with the patient" device evaluation: the zisv6-35-80-6.0-40-ptx device of lot number c1470885 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.There are two complaints related to this device.This complaint details the investigation for the separation of the retraction wire from the stent retraction sheath (srs) which caused the thumbwheel to malfunction.For details of the second investigation refer to (b)(4).No images were available for evaluation for this occurrence.A 0.035¿ terumo hydrophilic wire guide was used during stent deployment.No damage was noted on the wire guide prior to the procedure and the customer confirmed the device was flushed as per the instructions for use (ifu) and post-dilation was conducted using a 0.014¿ wire guide after deployment.According to the information provided, after encountering resistance in withdrawing the complaint device, the 0.035¿ wire guide was cut and left in the delivery system.The patient¿s lesions were described as calcified and high resistance was encountered as the stent was deployed.The customer confirmed difficulty was encountered during deployment after the first 2 cm of the stent had been deployed.The customer stated there was evidence of stent deformation post deployment.Stent compression was not noticed.The stent was eventually deployed.The target site was confirmed as the proximal part of the superficial femoral artery (sfa).The stent was fully placed before the delivery system and the wire guide were withdrawn.The device related to this occurrence underwent a laboratory evaluation on the 28 june 2018.On evaluation of the returned device, kinks and crinkle damage was noticed on the stability sheath (ss).The red safety trigger had been depressed and the device was returned without the stent.The stent retraction sheath (srs) had separated just distal to the coil/braid junction, 46.0 cm from the strain relief.The overall length was noted as 80.0 cm which was within the specification of 80.0cm +1/-2cm.A portion of the wire guide had been removed from the device.The remaining wire guide was found to be 0.032¿ (in diameter) and 67.4 cm in length.A 0.035¿ wire guide was successfully passed through the device with no resistance.The device was flushed with no issues.The thumbwheel rotated freely.The device handle was opened and the retraction wire was found separated from the srs.Complaint is confirmed as the failure was verified in the laboratory.The retraction wire was found to be separated during the evaluation.Possible root causes for this occurrence could include difficult patient anatomy.The calcified patient anatomy may have caused or contributed to the resistance during deployment.The resistance may have caused or contributed to the separation of the retraction wire causing the thumbwheel to malfunction and difficulty in deploying the stent.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 the user 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 zisv6-35-80-6.0-40-ptx device of lot number c1470885 contains zvsp6-t-35-80-6.0-40-is of lot number ch1447548.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 c1470885.Summary: complaint is confirmed as the failure was verified in the laboratory.The retraction wire was found to be separated during the evaluation.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

Mdr is being submitted based on the device malfunction precedence: ¿thumbwheel malfunctions during deployment", "retraction wire separates from stent retraction sheath" and "stent shortening/compression during deployment".There was a problem with the device.Not other information received.Puncture of the femoral artery on a wire placement of a 6 fr introducer.Pre dilatation a pta5 35 80 5 4.0 control and a need to placed a stent on the wire placement of the stent without problem starts to deploy the stent and after 2 cm impossible to continue to deploy the stent and the stent compressed on him self continue to deploy but the stent don't deploy correctly( invagination on him self) doctor think that the wire was blocked in a struck of the stent he takes a.014 wires and placed in the stent without problem and the stent was free from the.035 wire also problem to retrieve the deployment system.The doctor decide to leave the.014 wire in place and cut the.035 and retrieve the system with a piece of wire in the system on the.014 placed a catheter change for a.035 wire make a post dilatation in the stent and deployed correctly no problem with the patient.

Event Description

Mdr is being submitted based on the device malfunction precedence: ¿thumbwheel malfunctions during deployment", "retraction wire separates from stent retraction sheath" and "stent shortening/compression during deployment".There was a problem with the device.Not other information received "as per complaint form": puncture of the femoral artery on a wire placement of a 6 fr introducer.Pre dilatation a pta5 35 80 5 4.0 control and a need to placed a stent on the wire placement of the stent without problem starts to deploy the stent and after 2 cm impossible to continue to deploy the stent and the stent compressed on him self continue to deploy but the stent don't deploy correctly( invagination on him self) doctor think that the wire was blocked in a struck of the stent he takes a.014 wires and placed in the stent without problem and the stent was free from the.035 wire also problem to retrieve the deployment system.The doctor decide to leave the.014 wire in place and cut the.035 and retrieve the system with a piece of wire in the system on the.014 placed a catheter change for a.035 wire make a post dilatation in the stent and deployed correctly no problem with the patient.

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.

• 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: 7658736
• MDR Text Key: 113507643
• Report Number: 3001845648-2018-00300
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002353074
• UDI-Public: (01)10827002353074(17)200130(10)C1470885
• 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: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2020
• Device Catalogue Number: ZISV6-35-80-6.0-40-PTX
• Device Lot Number: C1470885
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/03/2018
• Event Location: Hospital
• Date Manufacturer Received: 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1