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

Catalog Number ZISV6-35-125-5-60-PTX

Device Problem Off-Label Use (1494)

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

Event Date 12/04/2023

Event Type  Injury  

Event Description

Per rep - 04dec2023 - they had access on the right groin.The patient already had a left fem pop bypass and already had bilateral kissing iliac artery stents.They went up and over with a 6 fr 655 high flex ansel sheath.They used a second high flex ansel sheath because the first one got crinkled (b)(4) but it worked.They went to use the second and it got ripped in half (b)(4).It may have gotten snagged on one of the prior placed stents.When they were pulling back on the sheath they realized it was pulled in half.The distal marker on the stent broke off (b)(4) along with the distal part of the high flex ansel sheath.They cut down on the left groin to pull out the foreign bodies from the sheath and the distal marker of the stent.The rep confirmed that foreign bodies from the products were successfully removed from the patient.Was patient hospitalized - already in-patient and it was an add on delay or additional procedure - surgery to remove foreign bodies addtl procedure due to product - surgery to remove foreign bodies adverse effects on patient -none other than cut down adv effects due to product -none other than cut down prefix ziv6-ptx/zisv6-ptx 3.60 are images (e.G.Angiography, us etc.) of the device and/or procedure available? n/a, yes, no -yes 3.61 was the device flushed before the procedure, as per ifu? n/a, yes, no -yes 3.62 were there any issues with flushing of the device? n/a, yes, no -no 3.63 details of the access sheath used (name, fr size,length)? - 3.64 details of the wire guide used (name, diameter, hyrdophyllic)? -035 320 road runner hydrophyllic angeld standard shaft 3.65 what approach was used to access the target site? contralateral, ipsilateral, antegrade, retrograde, other -3 entry points - main contralateral right groin access, left popliteal access and left ct access ¿ please specify for other: ¿ if contralateral, was the bifurcation angle steep? n/a, yes, no -yes 3.66 what was the target location for the stent? -left iliac - not per ifu 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 -other ¿ please specify for other: -left iliac artery 3.68 was the wire guide removed from the patient prior to advancing the delivery system? n/a, yes, no -no 3.69 if removed, was the wire guide wiped prior to advancement of the delivery system? n/a, yes, no -n/a 3.70 did the stent delivery system cross the target location? n/a, yes, no -yes 3.71 was pre-dilation performed ahead of placement of the stent? n/a, yes, no -yes 3.72 was the patient¿s anatomy difficult or altered? previous bypass, tortuous, calcified, altered, other -yes ¿ if other, please specify: -all of the above 3.73 was resistance encountered when advancing the wire guide? n/a, yes, no -yes 3.74 was resistance encountered when advancing the delivery system to the target location? n/a, yes, no -no 3.75 was resistance encountered when deploying the stent? n/a, yes, no -no 3.76 how did the physician deal with any resistance encountered? -n/a 3.77 was the stent fully deployed in the patient before removing the delivery system? n/a, yes, no -yes 3.78 after deployment did the stent show signs of any of the following: compression, fracture, deformation, constraint, elongation, other -constraint due to plaque ¿ if other, please specify: 3.79 was post-dilation performed after the placement of the stent? n/a, yes, no -no, because it was ripped in half 3.80 did any portion of the device break off? n/a, yes, no -yes ¿ if yes, please state what part: -distal marker 3.81 when did the device break? n/a, prep, advancement, deployment, withdrawal, after removal -deployment after withdrawal 3.82 thumbwheel only ¿ was the distal end of the stability sheath inside the access sheath? n/a, yes, no -yes 3.83 thumbwheel only ¿ was the retraction sheet being held during deployment.N/a, yes, no -no 3.84 did the thumbwheel spin freely or rotate without stent release or without retracting the stent retraction sheath? n/a, yes, no -yes ¿ if yes, was the stent partially deployed? n/a, yes, no -completely deployed ¿ if yes, was the partially deployed stent removed with the delivery system or was it deployed in the patient? n/a, removed, deployed -completely deployed 3.85 if removed, did any part of the stent fracture during removal of the delivery system? n/a, yes, no -yes 3.86 was the delivery system kinked or twisted during advancement or deployment? n/a, yes, no -no 3.87 please advise if and when any damage was observed on the; 3.87.1 wireguide n/a, yes, no -no ¿ prior to use, during use, post procedure -n/a 3.87.2 delivery system n/a, yes, no -distal marker ¿ prior to use, during use, post procedure -during use, when pulling out ¿ if yes, please specify (e.G.Kinked or twisted): -no 3.88 what intervention (if any) was required? -surgery 3.89 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 -yes, same day 3.90 were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? n/a, yes, no -kinked and twisted ¿ please specify if yes.

• 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: 18380568
• MDR Text Key: 331184409
• Report Number: 3005580113-2023-00128
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384078
• UDI-Public: (01)10827002384078(17)250731(10)C2103895
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-5-60-PTX
• Device Lot Number: C2103895
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/21/2023
• Distributor Facility Aware Date: 12/04/2023
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2023
• Date Device Manufactured: 10/18/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 76 KG