MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; Stent, superficial femoral artery, drug-eluting

Model Number	G38491
Date of Event	01/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Niu stent, superficial femoral artery, drug-eluting.
Event or Problem Description
Reported by the dm on behalf of the customer via email - when attempting to deploy the stent the physician started to the thumb wheel rotation with initial retraction of the retraction sheath.Before the stent was exposed the retraction sheath stopped moving even though the physician was continuing to rotate the thumb wheel.The physician decided to remove the deployment system but the system would not go back into the 6fr sheath.The physician removed the whole system and sheath wire.Once the system was removed it was noticed that the white nose cone came detached from the delivery system and left in the popliteal artery.The nose cone was snared and removed from the patient.The procedure was completed with two other g38491/lot #c2001290.Patient outcome: the following has been answered- jm 16jan2023.1.Did any unintended section of the device remain inside the patient¿s body? if yes, please describe.Yes! the white nose cone of the delivery system broke off and traveled down into the rt tp trunk.2.Did the patient require any additional procedures due to this occurrence? yes! 3.Did the product cause or contribute to the need for additional procedures? if yes, please specify additional procedures and provide details.Yes! the physician had to snare the broken piece out of the patient.4.Has the complainant reported any adverse effects on the patient due to this occurrence? it was reported to the risk management department at the hospital.5.Has the complainant reported that the product caused or contributed to the adverse effects? please specify adverse effects and provide details.Yes.6.Was the patient hospitalized or was there prolonged hospitalization due this occurrence? no! patient/event info - notes: prefix ziv6-ptx/zisv6-ptx.The following has been answered- jm 16jan2023.1.Are images (e.G.Angiography, us etc.) of the device and/or procedure available? n/a, yes, no.Yes and already sent with original email.2.Was the device flushed before the procedure, as per ifu? yes.3.Were there any issues with flushing of the device? no.4.Details of the access sheath used (name, fr size, length)? 6fr x 70cm raabe cook sheath.5.Details of the wire guide used (name, diameter, hydrophilic)?.014 x 330cm viper wire (csi) after the stent wouldn¿t deploy we swapped out the.014 wire for an.035 x 300 supercore wire (abbott).This did not help with deployment.6.What approach was used to access the target site? contralateral.If contralateral, was the bifurcation angle steep? no.7.What was the target location for the stent? mid/distal rt sfa.8.What artery was the stent placed in? proximal sfa, mid sfa, distal sfa, at the ostium of the profunda, p1 (proximal popliteal), other.¿ please specify for other: mid/distal sfa.9.Was the wire guide removed from the patient prior to advancing the delivery system? no.10.If removed, was the wire guide wiped prior to advancement of the delivery system? no wire guide was not removed.11.Did the stent delivery system cross the target location? yes.12.Was pre-dilation performed ahead of placement of the stent? yes.13.Was the patient¿s anatomy difficult or altered? previous bypass, tortuous, calcified, altered, other.If other, please specify: calcified.14.Was resistance encountered when advancing the wire guide? no.15.Was resistance encountered when advancing the delivery system to the target location? no.16.Was resistance encountered when deploying the stent? no! physician started thumbwheel and retractor sheath started to retract but then stopped even though the thumbwheel was still be turned.17.How did the physician deal with any resistance encountered? 18.Was the stent fully deployed in the patient before removing the delivery system? no! stent was never deployed.It was decided to remove the deliver system but it would not come back through the 6fr sheath.The whole delivery system and sheath was completely removed from patient over a.035 x 300 supercore wire 19.After deployment did the stent show signs of any of the following: compression, fracture, deformation, constraint, elongation, other if other, please specify: stent was never deployed.20.Was post-dilation performed after the placement of the stent? n/a, stent was never deployed.21.Did any portion of the device break off? n/a, yes, no yes! the white nose cone on the end of the delivery system broke off inside the patient if yes, please state what part: 22.When did the device break? n/a, prep, advancement, deployment, withdrawal?after removal at some point between attempted deployment and withdrawal.23.Thumbwheel only ¿ was the distal end of the stability sheath inside the access sheath? yes.24.Thumbwheel only ¿ was the retraction sheet being held during deployment.No.25.Did the thumbwheel spin freely or rotate without stent release or without retracting the stent retraction sheath? yes.If yes, was the stent partially deployed? no! stent was never deployed.The retractor sheath started to retract but then stopped and never retracted far enough for the deployment of the stent.If yes, was the partially deployed stent removed with the delivery? stent was never deployed.26.System or was it deployed in the patient? removed.27.If removed, did any part of the stent fracture during removal of the delivery system? no.28.Was the delivery system kinked or twisted during advancement or deployment? no.Please advise if and when any damage was observed on thewireguide no damaged observed on the.014 x 330cm viper wire prior to advancing the g38491 delivery system or after.Prior to use, during use, post procedure.31.Delivery system n/a, yes, no.Prior to use, during use, post procedure after removal we noticed the delivery system was damaged and the white nose cone was missing from the delivery system? if yes, please specify (e.G.Kinked or twisted).32.What intervention (if any) was required? physician had to snare the broken off nose cone to remove from patient.33.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day same time as procedure.34.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? n/a, yes, no.Please specify if yes.No defects where noticed prior to incident.The physician still had to treat the sfa lesion so before snaring the broken piece he stented the sfa with (2) g38491 lot# c2001290 the exact same as the defected one.However we had switched to a 7fr x 55cm raabe and over an.035 x 300cm supercore wire.Both g38491 deployed without any issues.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Common Device Name: Stent, superficial femoral artery, drug-eluting
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 16292873
• Report Number: 3005580113-2023-00019
• Device Sequence Number: 12375424
• Product Code: NIU
• UDI-Device Identifier: 10827002384917
• UDI-Public: (01)10827002384917(17)241018(10)C2001290
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/03/2023
• Report Date (Section F): 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/18/2024
• Device Model Number: G38491
• Device Catalogue Number: ZISV6-35-125-7-140-PTX
• Device Lot Number: C2001290
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/12/2023
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2023
• Date Device Manufactured: 11/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/03/2023