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

Model Number G38483

Device Problems Improper or Incorrect Procedure or Method (2017); Dent in Material (2526)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/27/2022

Event Type  malfunction  

Event Description

As reported to customer relations via phone conversation "the stent was a little under expanded after deployment.The physician indicated the wire was bent and he had to advance and retract the delivery system.The physician stated it appears the strut on the stent is bent.Therefore, another ptx was deployed across the proximal portion of the stent.Note: per dm, it's not clear (when the physician was advancing and retracting the delivery system )- if this caused the strut to bend.Did any unintended section of the device remain inside the patient¿s body? - no · if yes, please describe.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? - nothing reported to the dm did the patient require any additional procedures due to this occurrence? - no · if yes, please describe.Did the product cause or contribute to the need for additional procedures? - no · if yes, please specify additional procedures and provide details.Has the complainant reported any adverse effects on the patient due to this occurrence? - no has the complainant reported that the product caused or contributed to the adverse effects? - no · please specify adverse effects and provide details.3.60 are images (e.G.Angiography, us etc.) of the device and/or procedure available? - n/a 3.61 was the device flushed before the procedure, as per ifu? - asku 3.62 were there any issues with flushing of the device? - no 3.63 details of the access sheath used (name, fr size,length)? - 6fr ansel sheath 3.64 details of the wire guide used (name, diameter, hyrdophyllic)? - versacore.035 3.65 what approach was used to access the target site? - contralateral and retrograde ¿ please specify for other: ¿ if contralateral, was the bifurcation angle steep? - no 3.66 what was the target location for the stent? - proximal sfa 3.67 what artery was the stent placed in? proximal sfa, mid sfa, distal sfa, at the ostium of the profunda, p1 (proximal popliteal), other - proximal sfa please specify for other: 3.68 was the wire guide removed from the patient prior to advancing the delivery system? - no 3.69 if removed, was the wire guide wiped prior to advancement of the delivery system? - n/a 3.70 did the stent delivery system cross the target location? - yes 3.71 was pre-dilation performed ahead of placement of the stent? - yes 3.72 was the patient¿s anatomy difficult or altered? - no if other, please specify: 3.73 was resistance encountered when advancing the wire guide? - asku 3.74 was resistance encountered when advancing the delivery system to the target location? - no 3.75 was resistance encountered when deploying the stent? - no 3.76 how did the physician deal with any resistance encountered? - see event description 3.77 was the stent fully deployed in the patient before removing the delivery system? - yes 3.78 after deployment did the stent show signs of any of the following: - compression & constraint (the very proximal portion) if other, please specify: 3.79 was post-dilation performed after the placement of the stent? - yes 3.80 did any portion of the device break off? - no if yes, please state what part: - n/a 3.81 when did the device break? n/a, 3.82 thumbwheel only ¿ was the distal end of the stability sheath inside the access sheath? n/a 3.83 thumbwheel only ¿ was the retraction sheet being held during deployment.N/a 3.84 did the thumbwheel spin freely or rotate without stent release or without retracting the stent retraction sheath? - asku if yes, was the stent partially deployed? n/a if yes, was the partially deployed stent removed with the delivery system or was it deployed in the patient? n/a 3.85 if removed, did any part of the stent fracture during removal of the delivery system? n/a 3.86 was the delivery system kinked or twisted during advancement or deployment? - no 3.87 please advise if and when any damage was observed on the; 3.87.1 wire-guide - yes the wire guide bent prior to use, during use, post procedure 3.87.2 delivery system - no prior to use, during use, post procedure if yes, please specify (e.G.Kinked or twisted): - n/a 3.88 what intervention (if any) was required? - none 3.89 was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, 3.90 were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? - n/a please specify if yes.- n/a.

Manufacturer Narrative

Pma #: p100022/s026.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

Pma/510(k) # p100022/s026.Device evaluation: the zisv6-35-125-6-140-ptx device of lot number c1937834 involved in this complaint was implanted in the patient and was not available for evaluation.With the information provided, a document-based investigation was conducted.Lab evaluation: the device lab evaluation could not be completed as the device, or photographic evidence of the device, was not returned for evaluation.Document review: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.Historical data review: the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Ifu & label review: there is evidence to suggest that the customer did not follow the instructions for use which 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.¿ from the information received, in the description of the event and the additional questions, it states that the physician noted that the wire was bent and he had to advance and retract the delivery system.As per dm, its not clear when the physician was advancing and retracting the delivery system ¿ if this caused the strut to bend.As per engineering input ¿that kink affected getting our device to/across the target site because they say "the physician indicated the wire was bent and he had to advance and retract the delivery system".Per the ifu, they should have removed the ptx device completely when they felt resistance¿they persisted in trying to get the ptx device over the kinked wire guide.They should have stopped as soon as they saw a damaged wire guide¿.Image review: an image was not returned for evaluation.Root cause review: a definitive root cause of use error was determined.The physician stated that he noted damage on the wire guide and said that the wire guide was bent.He had to advance and retract the delivery system and as per dm it's not clear (when the physician was advancing and retracting the delivery system ) if this caused the strut to bend.As per engineering input ¿that kink affected getting our device to/across the target site because they say "the physician indicated the wire was bent and he had to advance and retract the delivery system.Per the ifu, they should have removed the ptx device completely when they felt resistance.They persisted in trying to get the ptx device over the kinked wire guide.They should have stopped as soon as they saw a damaged wire guide¿.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.Another ptx stent was deployed across the proximal portion of the stent.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation on 31-jan-2023 and an update to the investigation conclusions.

• 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
• 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: 15292782
• MDR Text Key: 305517620
• Report Number: 3001845648-2022-00578
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384832
• UDI-Public: (01)10827002384832(17)240311(10)C1937834
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2024
• Device Model Number: G38483
• Device Catalogue Number: ZISV6-35-125-6-140-PTX
• Device Lot Number: C1937834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/27/2022
• Event Location: Hospital
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2022
• 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 Sex: Female