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

Catalog Number ZIV6-35-125-7.0-100-PTX

Device Problems Fracture (1260); Implant, removal of (2320)

Patient Problems Unspecified Infection (1930); Pain (1994); Surgical procedure (2357)

Event Date 04/25/2014

Event Type  Injury  

Event Description

On (b)(6) 2014 the left upper femoral artery was recanalized.The implanted stents were occluded one day after the procedure.The pt had pain at the level of sfa which did not subside with time.Fluoroscopy on the (b)(6) 2014 showed a stent fracture and the artery had sutured a purulent infection.The pt had a femoropopliteal pars iii venous bypass made up from the great saphenous vein and an arm vein.The stent was extracted with open surgery and abscess in the middle part of the upper femoral artery was drained.Further procedures: iv augmentin 3 x 2.2 g until bacteriology results are obtained, heparin as prescribed.Three weeks later the pt went home.The foot-pulse was palpable.The inflammatory parameters were better.

Manufacturer Narrative

The stents involved in this complaint are ziv6-35-125-7.0-100-ptx, lot numbers c921190 and c921189 and ziv6-35-125-6.0-100-ptx, lot # c921188.It is not known which stent experienced the fracture.There were no zilver ptx devices of lot numbers c921190, c921189 and c921188 in stock at the time of the complaint investigation.The stents were not available for eval.With the info provided a document based investigation was carried out.Images were sent for clinical review.The findings and impression from this review are as follows: findings: the only imaging submitted for review is twenty-one undated images from an angiogram.In multiple images a type iv stent fracture is noted.Per the report the stent was fractured and the artery suffered a purulent infection and had to be extracted with open surgery.Impression: per the report the stent was fractured and the artery suffered a purulent infection and had to be extracted with open surgery.There are twenty-one undated images submitted for review.There is no indication of how long after the stent was implanted that it was found to be fractured.Without procedural imaging from the initial implant there is no way to determine how or when the stent was fractured or what led to the infection.' the complaint is confirmed based on the images and customer testimony.According to the initial treatment report for placement of the ptx stents "after local anaesthetic (during which the pt experiences severe pain), the left common femoral artery was entered and a 6f sheath was placed in it.A terumo wire was used to bridge the stenoses and the obstruction was passed subintimally guided by a balloon.Re-entry was unsuccessful until an outback catheter was used.The entire section, which displayed severe atherosclerotic changes, was supplied from distal to proximal with drug-eluting stents and then dilated.A stenosis in the exit area was dilated using only a 6/40 balloon." "final angiography showed no unhindered flow of contrast medium, no indication of complications." according to the operation report to remove the fractured stent "the femoral bifurcation was exposed and had calcified like stone.The popliteal artery was exposed above and below the knee and prepared for doing the bypass.The upper femoral artery was exposed at the site marked before the operation.There were massive signs of inflammation in the vicinity of the artery, which was distended.A diagonal cut was made and material suspected of being infected was removed and sent off for analysis." "extraction of the stent to the extent that is possible from this site.After heparinization, there was an e/s anastomosis done with the vein that had not been turned.That was tedious because of the calcification.On the distal side, the arm vein piece was anastomosized with 7-0 ekn and the bypass was done orthotopically to the part below the knee.This was followed by an e/s anastomosis toward the popliteal artery, which again was tedious because of the calcification.Venting and release of the circulation, with a strong signal to the foot that depended on the bypass." according to the complaint from and surgical report the infection was identified as propioni bacteria.Additionally the surgical stated that "the pt was administered iv antibiotic therapy aimed at antibiotic-resistant microorganisms.Foot pulses were always strong.The abscess was rinsed daily, and it diminished significantly by the time he was discharged.The inflammation parameters also went down and the pain along with them"."the dopler check prior to discharge showed an unremarkable normally-perfused bypass.The abi values were left 1.03 and right 0.69." it may be noted that zilver ptx stent is fully endothelialized after approx 2 months and further neointimal coverage is progressing.After this time there may be reduced likelihood for a stent fracture.As per instructions for use stent strut fracture and allergic reaction to nitinol are noted as potential adverse events associated with the placement of this device.A definitive root cause of this event cannot be determined at this time.A review of the manufacturing records for zilver ptx and zilver ptx drug eluting stent revealed no discrepancies that could have contributed to this complaint.Further review by manufacturing engineering of the stents involved in this complaint also show no discrepancies that could have contributed to this complaint.The risk was assessed for this complaint was determined to be moderate.Quality engineering will continue to monitor complaints of this nature 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; limerick ; EI
• Manufacturer Contact: tracy o'sullivan ; 61334440
• MDR Report Key: 3862733
• MDR Text Key: 4457016
• Report Number: 3001845648-2014-00088
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• PMA/PMN Number: P100022/S001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2015
• Device Catalogue Number: ZIV6-35-125-7.0-100-PTX
• Device Lot Number: C921190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/25/2014
• Event Location: Hospital
• Date Manufacturer Received: 04/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2013
• 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; Required Intervention
• Patient Age: 69 YR