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

Model Number G38482

Device Problem Fracture (1260)

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

Event Date 10/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k) # p100022/s014.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: ¿stent fracture".As reported to customer relations, "stent catheter would not cross lesion.Re-attempt after pta of vessel, stent catheter had issues with wire going through catheter wire end hole.Finally wire went in and tried to track system over same wire and would not pass through entire system.Case was successful with competitor product.Physician deployed stent on table to check issues and stent was cracked and jumped out of delivery system.Patient not harm.".

Manufacturer Narrative

(b)(4).Exemption number: e2016031.Importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).Pma/510(k) # p100022/s014.This follow up report is being submitted due to the completion of the investigation into this event and the conclusion of this investigation.The zisv6-35-125-6-120-ptx device of lot number c1383036 involved in this complaint has not yet been returned for evaluation.With the information provided, a document based investigation was conducted.The investigation will be updated once the complaint device has been returned and evaluated.From customer testimony, it is known that the complaint device was used with a 0.018¿ glide wire and 0.035¿ diameter glide wire guides.The wire guides were hydrophilic, they were used previously and were wiped infrequently between uses.The wire guide end was shredded after several attempts were made to advance the complaint device.The complaint device was flushed prior to use.The patient anatomy was heavily calcified.The procedure was three minutes between advancing the complaint device and removing the device.The district manager has confirmed that when the complaint device delivery system was removed from the patient, the stent was deployed on a table (outside the patient anatomy) and it was observed that the stent was fractured/broken.The physician stated that the procedure lasted three hours in total, and indicated that if he had pre-dilated it may have helped and made a difference during the procedure.There is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.The customer stated that the complaint device was used with a 0.018¿ and a 0.035" diameter wire guide.Possible causes for this occurrence could include the heavily calcified anatomy, and/or the use of a non-recommended, 0.018" diameter wire guide.Further clarification has been requested in regards to the use of the wire guides.The calcified anatomy could have created the resistance encountered during advancement, and a non-recommended wire guide could have provided insufficient support during advancement.These factors could have caused or contributed to the inability to advance the complaint device across the lesion, as well as the damage on the wire guide and stent.However, as the device has not yet been returned for evaluation, and the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.From the product instructions for use: "if resistance is met during advancement of the delivery system, do not force passage.Remove the delivery system and replace with a new device." 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¿.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 c1383036.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The procedure was completed with a competitors product.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This follow up report is being submitted due to the completion of the investigation into this event and the conclusion of this investigation.Initial mdr details: initial mdr is being submitted based on the device malfunction precedence: ¿stent fracture".As reported to customer relations, "stent catheter would not cross lesion.Re-attempt after pta of vessel, stent catheter had issues with wire going through catheter wire end hole.Finally wire went in and tried to track system over same wire and would not pass through entire system.Case was successful with competitor product.Physician deployed stent on table to check issues and stent was cracked and jumped out of delivery system.Patient not harm." additional information received on 09-nov-17 as follows: "physician deployed stent on table to check issues and stent was cracked and jumped out of delivery system." was the stent fractured / broken on deployment? - per dm, yes.

Manufacturer Narrative

(b)(4).Exemption number: e2016031.Importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).Pma/510(k) # p100022/s014.This follow up report is being submitted to inform fda that the complaint device has been received and a lab evaluation is pending.A follow up mdr will be submitted within 30 days with the final investigation conclusions.

Event Description

This follow up report is being submitted to inform fda that the complaint device has been received and a lab evaluation is pending.A follow up mdr will be submitted within 30 days with the final investigation conclusions.Initial mdr details: initial mdr is being submitted based on the device malfunction precedence: ¿stent fracture".As reported to customer relations, "stent catheter would not cross lesion.Re-attempt after pta of vessel, stent catheter had issues with wire going through catheter wire end hole.Finally wire went in and tried to track system over same wire and would not pass through entire system.Case was successful with competitor product.Physician deployed stent on table to check issues and stent was cracked and jumped out of delivery system.Patient not harm." additional information received on 09-nov-17 as follows: "physician deployed stent on table to check issues and stent was cracked and jumped out of delivery system."was the stent fractured / broken on deployment? - per dm, yes.

Event Description

This follow up report is being submitted due to the evaluation of the device involved in this event and the conclusion of this investigation.Initial mdr details: initial mdr is being submitted based on the device malfunction precedence: ¿stent fracture".As reported to customer relations, "stent catheter would not cross lesion.Re-attempt after pta of vessel, stent catheter had issues with wire going through catheter wire end hole.Finally wire went in and tried to track system over same wire and would not pass through entire system.Case was successful with competitor product.Physician deployed stent on table to check issues and stent was cracked and jumped out of delivery system.Patient not harm." additional information received on 09-nov-17 as follows: "physician deployed stent on table to check issues and stent was cracked and jumped out of delivery system." was the stent fractured / broken on deployment? per dm, yes.

Manufacturer Narrative

(b)(4).Exemption number: e2016031.(b)(4).Pma/510(k) #: p100022/s014.This follow up report is being submitted due to the evaluation of the device involved in this event and the conclusion of this investigation.The zisv6-35-125-6-120-ptx device of lot number c1383036 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.From customer testimony, it is known that the complaint device was used with a 0.018¿ glide wire and 0.035¿ diameter glide wire guides.The wire guides were hydrophilic, they were used previously and were wiped infrequently between uses.The wire guide end was shredded after several attempts were made to advance the complaint device.The complaint device was flushed prior to use.The patient anatomy was heavily calcified.The procedure was three minutes between advancing the complaint device and removing the device.The district manager has confirmed that when the complaint device delivery system was removed from the patient, the stent was deployed on a table (outside the patient anatomy) and it was observed that the stent was fractured/broken.The customer stated that the complaint device was initially advanced over a 0.014¿ diameter, boston scientific wire guide.However, when the device would not advance, the device and the wire guide were removed, and the device was advanced over a 0.035¿ diameter, terumo stiff glide wire.Both wire guides were damaged.The district manager also clarified that the complaint device was used with a 0.014¿ diameter wire guide, not a 0.018¿ diameter wire guide.The physician stated that the procedure lasted three hours in total, and indicated that if he had pre-dilated it may have helped and made a difference during the procedure.No images related to this event have been provided to date.On evaluation of the returned device, bends and kinks was observed in the stability sheath (ss), distal to the strain relief.The distal stent retraction sheath (srs) was shape set, and crinkle damage was noted.The device was returned with the safety trigger depressed.The srs was bent, 43cm from the distal end of the srs.The distal inner component was separated at a point corresponding to the bend in the srs.The device was flushed without issues.A 0.035¿ diameter wire guide was passed through the distal inner component without issues.It was not possible to pass a 0.035¿ diameter wire guide through the handle, with the wire guide stopping at the strain relief.The device was returned with 10cm of the stent still loaded in the srs, and there was evidence that the stent was fractured.The device handle was opened, and it was found that the stent retraction wire was separated from the stent retraction sheath.Complaint is confirmed as the failure was verified in the laboratory.It was not possible to pass a wire guide through the device handle.The customer stated that the complaint device was used with a 0.014¿ and a 0.035" diameter wire guide.Possible causes for this occurrence could include the heavily calcified anatomy, and/or the use of a non-recommended, 0.014" diameter wire guide.The calcified anatomy could have created the resistance encountered during advancement, and a non-recommended wire guide could have provided insufficient support during advancement.These factors could have created the bends and kinks noted in the stability sheath, and caused or contributed to the inability to advance the complaint device across the lesion.The bends and kinks in the stability sheath could have created resistance when the physician attempted to deploy the stent, which could have caused the break in the distal inner, and the stent retraction wire to separate from the stent retraction sheath.However, as the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.From the product instructions for use: "if resistance is met during advancement of the delivery system, do not force passage.Remove the delivery system and replace with a new device." 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.¿ 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 c1383036.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The procedure was completed with a competitors product.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 7037382
• MDR Text Key: 93380418
• Report Number: 3001845648-2017-00553
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384825
• UDI-Public: (01)10827002384825(17)180522(10)C1383036
• 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,Followup
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G38482
• Device Catalogue Number: ZISV6-35-125-6-120-PTX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/06/2017
• Event Location: Hospital
• Date Manufacturer Received: 12/12/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1