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

Model Number G38488

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 09/09/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: p100022/s014.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Reported by phone call from the dm- when attempting to place the first stent, the stent would not go through the lesion but the second stent went past the lesion and was able to cross.It is believed something is wrong with the delivery system of the first stent.Fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿thumbwheel malfunctions during deployment¿.No adverse effects to the patient have been reported as occurring.

Event Description

Reported by phone call from the dm- when attempting to place the first stent, the stent would not go through the lesion but the second stent went past the lesion and was able to cross.It is believed something is wrong with the delivery system of the first stent.Fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿thumbwheel malfunctions during deployment¿.No adverse effects to the patient have been reported as occurring.This report is being submitted as a cancellation report.From the initial information received, this event was cautiously made reportable based on the precedence in place for this device of 'thumbwheel malfunctions during deployment¿.However, when the returned device was received it was confirmed during the lab evaluation that this malfunction did not occur.The following failure has been confirmed: "retraction sheath cannot reach target site".Overall risk assessed as category iia (low).No reporting malfunction precedence exists for this complaint event for this product family.Low risk of failure mode indicates no potential for serious injury if the malfunction were to recur.

Manufacturer Narrative

Pma/510(k) #: p100022/s014.Device evaluation: the zisv6-35-125-7-80-ptx device of lot number c1617097 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.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 17 october 2019.Refer to (b)(4) evaluation notes for lab attendance and notes.The returned device lab examination findings and observations can be referred through attached photos.On evaluation of the device it was observed that there was no damage on the outer sheath.The device was flushed with no issues and a 0.035¿ wire guide passed through the device as expected.The distal tip position relative to the sheath was not as per specification (as received).The proximal end of the distal tip was approximately 3.0 mm outside of the distal end of the stent retraction sheath (srs).This is out of specification as per (b)(4); 2mm +0.5 / -0.0.However, as each lot undergoes a 100% inspection prior to distribution as per (b)(4) it is unlikely that the device left the manufacturing site this way.(b)(4) limits the potential for nonconforming lots to leave the manufacturing site.Document review: prior to distribution zisv6-35-125-7-80-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.(b)(4) instructs the manufacturing team members (mtm) to conduct a 100% inspection of each lot.(b)(4) step 2f instructs the mtm of the following: ¿using the microscope (10x) attached to the thumbwheel ptx inspection tool; verify the tip is sitting in the correct position relative to the sheath.The white transition line on the tip cannot pass the clear section of the sheath.Confirm there is a smooth transition between the sheath and tip ¿ ensure there is no flash on distal end of sheath.Inspection method: manually feel and visually examine under the microscope.¿ a review of the manufacturing records for zisv6-35-125-7-80-ptx of lot number c1617097 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 c1617097.The instructions for use (b)(4) states the following: ¿if resistance is met during advancement of the delivery system, do not force passage.Remove the delivery system 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¿s anatomy was calcified.It is possible that this contributed to resistance during advancement of the device.It is possible that the distal white tip moved upon removal of the device from the patient as it was confirmed from the information provided that there was resistance when the user began to remove the device from the patient.Summary: the complaint is confirmed based on customer testimony.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.

• 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: 9165125
• MDR Text Key: 189904240
• Report Number: 3001845648-2019-00512
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384887
• UDI-Public: (01)10827002384887(17)201108(10)C1617097
• 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: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2020
• Device Model Number: G38488
• Device Catalogue Number: ZISV6-35-125-7-80-PTX
• Device Lot Number: C1617097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/09/2019
• Event Location: Hospital
• Date Manufacturer Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1