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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia (1942); Pain (1994); Obstruction/Occlusion (2422); Tissue Breakdown (2681)

Event Type  Injury  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Zamani et al 2020 ¿ (zilver ptx)¿outcomes after endovascular stent placement for long-segment superficial femoral artery lesions¿.All cases were either primarily stented or followed angioplasty when the degree of residual stenosis exceeded 50% or when a flow-limiting dissection was identified.Technical success was defined as re-establishment of sfa patency with flow across the target lesion with less than 30% re-sidual stenosis on completion angiography.The des (n=57) was self-expanding nitinol stents with a polymer-free pacli-taxel coating (zilver ptx; cook medical, blooming-ton, in).Target lesion revascularization.Symptoms at stent occlusion included claudication (4), rest pain or tissue loss (6) and acute limb ischemia (ali) (1).Stented lesions collectively required 11 endovascular and 2 open revascularization attempts.The vast majority of both endovascular and open reinterventions occurred within 18 months of initial stent placement.Among the cases with ali, 8 (47% of overall cohort) required an open arterial bypass of the target lesion, all of whom were in patients initially treated with cs.

Manufacturer Narrative

Device evaluation: the zisv6 devices of unknown lot number involved in this complaint were implanted in the patients and were not available for evaluation.With the information provided, a document based investigation was conducted.Document review: as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution zisv6 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.Symptoms at stent occlusion included claudication, rest pain or tissue loss and acute limb ischemia.It should be noted that the instructions for use (ifu0118) list ischemia requiring intervention and worsened claudication/rest pain as potential adverse events.There is no evidence to suggest the user did not follow the ifu.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient pre existing/underlying conditions.From the literature article it is known that the patients were treated for symptomatic long-segment superficial femoral artery (sfa) disease.It is possible that patient pre-existing conditions caused and/or contributed to ischemia and worsened claudication.As per the instructions for use, ischemia and worsened claudication are listed as potential complications following the placement of this device.Summary: complaint is confirmed based on customer testimony.As per clinical input (ref.Att.Re zamani clinical input.Msg) patients required intervention/additional procedures to prevent permanent impairment/damage.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report being submitted due to completion of investgation on 29-apr-2022.

• 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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 13042234
• MDR Text Key: 282487454
• Report Number: 3001845648-2021-00882
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 12/08/2021
• Supplement Dates FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 66 YR
• Patient Sex: Male