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 Improper or Incorrect Procedure or Method (2017)

Patient Problems Post Operative Wound Infection (2446); Pseudoaneurysm (2605)

Event Date 04/08/2022

Event Type  Injury  

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

Zenunaj et al 2022- superficial femoral artery access for infrainguinal antegrade endovascular interventions in the hostile groin: a prospective randomized study.Between 2020 and 2021, 107 patients who underwent antegrade revascularization were enrolled.Sfa was achieved in 50 cases by the femoral cutdown technique (c-group) and in 57 cases by percutaneous ultrasound-guided puncture (p-group).Femoral cutdown technique (n=15).A short segment of the sfa was exposed.The puncture was performed using a 19g needle passing from the skin toward the arterial wall.A standard guidewire was introduced; and over it a 6-fr sheath (12 cm long; ultimum ev introducer; abbott, (b)(4)) at the end of the procedure, the sheath was removed and the arterial hole was sutured with an absorbable suture (maxon 6e0), followed by a doppler check to evaluate the patency of the sfa.Then, hemostasis and standard wound closure were performed.Percutaneous puncture technique (n=22).The incision site was assessed preoperatively by ultrasound and the puncture was performed under local anesthesia with lidocaine 200 mg using a 19g needle.A standard guidewire was introduced, over it, a 6-fr sheath (12 cm long; ultimumev introducer).At the end of the procedure, the sheath was removed and hemostasis was performed using a 6-fr percutaneous closure device (pcd) (angio-sealvip 6-fr; terumo medical corporation, (b)(4)) six cases (12%, all in the obese subgroup and within 30 days) surgical wound complications occurred in the c-group versus one case the p-group (one of the 2 cases converted to cutdown).This complaint was opened to capture 6 cases of surgical wound complications in the c-group.This complaint also captures 15 cases of user error due to the use of the femoral cutdown technique in the c-group.(zilver ptx 35 drug-eluting stent).Related to pr (b)(4) / mdr ref#3001845648-2022-00469.As per clinical input - requirement for hospitalisation / prolong hospitalisation'.

Event Description

Supplemental follow-up mdr report is being submitted due to the completion of the investigation on 22-mar-2023 and an update to the investigation conclusions.

Manufacturer Narrative

Device evaluation the device evaluation could not be completed as the device involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.This file is related to (b)(4) ( emdr ref.- 3001845648-2022-00465) , (b)(4) (emdr ref.- 3001845648-2022-00467), (b)(4) ( emdr ref.- 3001845648-2022-00468 ) , (b)(4) ( emdr ref.- 3001845648-2022-00469 ) , (b)(4) (emdr ref.- 3001845648-2022-00860 ) , (b)(4) and it was created from the attached journal article.This complaint captures 15 cases of user error due to the use of the femoral cutdown technique in the c-group with surgical wound complications.(zilver ptx 35 drug-eluting stent) lab evaluation the device 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 zilver ptx devices are subjected to a visual inspection and functional inspection to ensure device integrity.Manufacturing records review could not be completed as the lot number is unknown.Historical data was not reviewed as the lot number is unknown.There is evidence to suggest the user did not follow the ifu.It should be noted that the instructions for use states that standard techniques for interventional vascular procedures should be employed however from the article it is known that the femoral cutdown technique was used for stent placement in the c-group.This would not be considered a standard technique.The instructions for use also lists pseudoaneurysm formation and vessel perforation or rupture, as possible adverse events.Image review an image was not returned for evaluation.Root cause review a definitive root cause of the user not reading or following the instructions for use has been determined.The instructions for use states that standard techniques for interventional vascular procedures should be employed however from the article it is known that the femoral cutdown technique was used for stent placement in the c-group.This would not be considered a standard technique.Also, as the paper does not specify exactly what complications occurred, a worse case scenario of vessel damage/ pseudoaneurysm is selected as the harm.The instructions for use lists pseudoaneurysm formation and vessel perforation or rupture, as possible adverse events.Summary the complaint is confirmed based on customer testimony.The complaint was raised from literature paper zenunaj et al ¿superficial femoral artery access for infrainguinal antegrade endovascular interventions in the hostile groin: a prospective randomized study¿.According to the initial reporter, the femoral cutdown technique was used in 15 cases with 06 surgical wound complications reported.The complications were ¿secondary to procedure not device¿ and would have required ¿hospitalisation/prolong hospitalisation¿.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 15964214
• MDR Text Key: 305341159
• Report Number: 3001845648-2022-00861
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/08/2022
• Event Location: Hospital
• Date Manufacturer Received: 06/28/2022
• 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): Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male