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

Catalog Number ZISV6-35-125-7.0-120-PTX

Device Problems Break (1069); Structural Problem (2506)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: p100022/s027.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

After the first 3 centimetres the wrist wheel broke the doctor had to do the deployment manually which resulted in the lengthening of the stent by about 10 centimetres.Ssc team update: info from cust 01-oct : during dilation of the patient's peripheral artery, when the self-expanding stent was placed, rupture of the sheath.The stent was removed + identical stent was placed, no difficulty.No consequences.Patient outcome: a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Pma/510(k) #: p100022/s027.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

This follow-up supplemental report is being submitted due to the receipt of additional information on 23-oct-2020 and completion of the complaint device evaluation on 12-nov-2020.Report also being re-assessed as a 'serious injury' report based on the assumption the deployed stent was removed from the patient.Clarification has been requested.Additional information received 23-oct-2020 as follows: 1.Are images of the device of procedure available? no 2.Was the approach ipsilateral or contralateral? contralateral 3.If contralateral, was the bifurcation angle tight? no tight 4.Was pre-dilation performed ahead of placement of the stent? yes 5.Was post-dilation performed after the placement of the stent?yes 6.Details of the wire guide used (name, diameter, hydrophylic)?n/a 7.Details of the access sheath used (name, fr size, length)?n/a 8.Was the device flushed before the procedure, as per ifu no 9.What was the target location for the complaint device? femoral superficial artery 10.Was the patient's anatomy tortuous or calcified? calcified 11.Was resistance encountered when advancing the wire guide to the target location? no 11a.How did the physician deal with this resistance?no resistance 11b.Was resistance encountered when advancing the delivery system to the target location? no resistance 11c.How did the physician deal with this resistance?no resistance 12.Did the stent delivery system cross the target location?yes 13.What artery was the stent placed in? femoral superficial artery 14.The event description states the "wrist wheel broke" does this mean the thumbwheel would not rotate to release the stent after the user had began deploying the stent? yes after 3 cm to depoiement 15.Was the complaint stent placed in the patient or was the device removed and the stent deployed outside the patient's body?in the patient 16.The event description states the stent stretched by about 10cm.Can i confirm that this is referring to the stent from this delivery system with the defective thumbwheel or if this refers to the replacement stent? defective thumbwheel 17.How did the user manually deploy the stent?pine and pool 18.What does the user mean by "rupture of the sheath"? defective thumbwheel 19.What part of the sheath is the user referring to as ruptured?after3 cm 20.At what point during the procedure did the sheath rupture? after3 cm 21.How many ptx devices were used during this procedure? only one 22.How many ptx devices did the user encounter difficulty with?only one device was evaluated on 12-nov-2020: severe crinkling was noted along the length of the sheath and the retraction wire was noted to be separated from the stent retraction sheath.Initial report details: after the first 3 centimetres the wrist wheel broke the doctor had to do the deployment manually which resulted in the lengthening of the stent by about 10 centimetres ssc team update: info from cust 01-oct : during dilation of the patient's peripheral artery, when the self-expanding stent was placed, rupture of the sheath.The stent was removed + identical stent was placed, no difficulty.No consequences patient outcome: a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Event Description

This follow-up supplemental report is being submitted due to the receipt of additional information on 11-dec-2020 as follows: "after the first 3 centimeters the wrist wheel broke the doctor had to do the deployment manually which resulted in the lengthening of the stent by about 10 centimetres the stent wasn't removed and stay in the patient".Report also being re-assessed as a 'malfunction' report based on the confirmation that the deployed stent was not removed from the patient.Initial report details: after the first 3 centimetres the wrist wheel broke the doctor had to do the deployment manually which resulted in the lengthening of the stent by about 10 centimetres.Ssc team update: info from cust 01-oct : during dilation of the patient's peripheral artery, when the self-expanding stent was placed, rupture of the sheath.The stent was removed + identical stent was placed, no difficulty.No consequences.Patient outcome: a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Pma/510(k) #: p100022/s027.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental report being submitted due to the investigation being completed on 16-apr-2021.After the first 3 centimetres the wrist wheel broke the doctor had to do the deployment manually which resulted in the lengthening of the stent by about 10 centimetres ssc team update: info from cust 01-oct : during dilation of the patient's peripheral artery, when the self-expanding stent was placed, rupture of the sheath.The stent was removed + identical stent was placed, no difficulty.No consequences.Patient outcome: a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Pma/510(k) #: p100022/s027.Device evaluation: the zisv6-35-125-7.0-120-ptx device of lot number c1738544 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 12 november 2020.On evaluation of the device severe crinkling was observed at the distal end of the outer sheath to approx.36.5 cm from the distal end of the outer sheath.The device flushed as expected but a 0.035¿ wire guide could not pass the crinkling on the outer sheath.The handle was disassembled in the lab and it was confirmed that the retraction wire was separated from the stent retraction sheath (srs).Document review: prior to distribution zisv6-35-125-7.0-120-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 zisv6-35-125-7.0-120-ptx of lot number c1738544 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.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1738544.It should be noted that the instructions for use (ifu0117-5) 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 difficult patient anatomy.From the information provided it is known that the patient exhibited a calcified anatomy.It is possible that this contributed to resistance during advancement resulting in the outer sheath becoming crinkled.It is likely that the difficult patient anatomy and the crinkling along the outer sheath contributed to increased deployment forces which resulted in the retraction wire separating from the srs during deployment.The user manually deployed the stent resulting in the stent becoming stretched.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.

Manufacturer Narrative

Pma/510(k) #: p100022/s027.Device evaluation: the zisv6-35-125-7.0-120-ptx device of lot number c1738544 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 12 november 2020.The returned device lab examination findings and observations can be referred through attached photos.On evaluation of the device severe crinkling was observed at the distal end of the outer sheath to approx.36.5 cm from the distal end of the outer sheath.The device flushed as expected but a 0.035¿ wire guide could not pass the crinkling on the outer sheath.The handle was disassembled in the lab and it was confirmed that the retraction wire was separated from the stent retraction sheath (srs).Document review: prior to distribution zisv6-35-125-7.0-120-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 zisv6-35-125-7.0-120-ptx of lot number c1738544 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.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1738544.It should be noted that the instructions for use (ifu0117-5) 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.Image review ¿ n/a.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 difficult patient anatomy.From the information provided it is known that the patient exhibited a calcified anatomy.It is possible that this contributed to resistance during advancement resulting in the outer sheath becoming crinkled.It is likely that the difficult patient anatomy and the crinkling along the outer sheath contributed to increased deployment forces which resulted in the retraction wire separating from the srs during deployment.The user manually deployed the stent resulting in the stent becoming stretched.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.

Event Description

This supplemental report is being submitted due to an update to the completion of the investigation on the 21-aug-2023.

• 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
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 10721703
• MDR Text Key: 249826413
• Report Number: 3001845648-2020-00812
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002352909
• UDI-Public: (01)10827002352909(17)220429(10)C1738544
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2022
• Device Catalogue Number: ZISV6-35-125-7.0-120-PTX
• Device Lot Number: C1738544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/24/2020
• Event Location: Hospital
• Date Manufacturer Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male