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

Catalog Number ZISV6-35-125-6-120-PTX

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation into this event is currently still in progress.A follow up report will be submitted with the investigation conclusions.

Event Description

The patient had a tight bifurcation.A (b)(4) was advanced over the bifurcation.Ptx delivery system was placed over a.014 wire; upon advancing over the bifurcation, the ptx delivery system kinked, not allowing advancement or removal of the system at this point the physician removed the.014 wire and tried to advance a.035 stiff glide wire through ptx delivery system without success and removed the wire.The physician tried to advance an amplantz extra stiff wire through ptx delivery system without success and removed the wire.At this point the entire ptx delivery system was retracted back across the bifurcation.Excessive force was needed to remove the ptx delivery system.Once the ptx delivery system was out of the patient, it was noted that the distal potion of the ptx stent system had separated/broken off, but remained in the sheath.At this point, the procedure was aborted.The physician cut the (b)(4) and advanced a 8.0 10cm terumo sheath over the (b)(4) in order to use closure device.

Manufacturer Narrative

Pma/510(k)#: p100022/s014.1 x zilver ptx device (zisv6-35-125-6-120-ptx, lot c1212390) was returned for evaluation.Device was not returned in the original package.On evaluation of the returned device it was confirmed that the stent was not deployed during the procedure.The access sheath used during this procedure was also returned with the complaint device.The access sheath was returned in two parts (note, the user cut the access sheath during the procedure).It was noted that the stent retraction sheath has separated from the complaint device distal to the stent stop, 1115mm from the distal end of the strain relief.According to the complaint description, ¿upon advancing over the bifurcation, the ptx delivery system kinked¿.It is possible the separation occurred where the compliant device kinked during advancement of the device.The stent retraction sheath wire appeared to have unraveled, which may be due to the stretching of the delivery system on withdrawal.It can be noted that the stent stop and proximal inner tubing were intact.According to the complaint description,¿.Excessive force was needed to remove the ptx delivery system.Once the ptx delivery system was out of the patient, ¿it was noted that the distal potion of the ptx stent system had separated/broken off, but remained in the sheath.¿ on visual examination of the returned device, the stent retraction sheath, stent, distal inner tubing and white tip were separated from the complaint device and were contained within the access sheath.It can be noted, that the separated portion of the delivery system could not be retrieved from the access sheath.Gross damage was noted to the access sheath, the unit was kinked and a section of the unit was concertinaed.Excessive damage was also noted along the length of the stability sheath.Numerous bends and kinking was evident.With force, engineering managed to partially deploy the stent, confirming the presence of the stent in the access sheath.However it was impossible to fully deploy the stent.The exposed section of the stent was confirmed to be intact and contained four gold rivets.It is possible that the excessive damage observed on the srs/ss may have been caused by the forces applied during retrieval of the device.During the lab evaluation r&d engineering opened the handle of the device and the inner components were visually examined.It has been confirmed that all components were assembled correctly.Upon examination of the returned device, there is no evidence to suggest that the device was manufactured incorrectly.According to the complaint information, the patient had a tight bifurcation, the user attempted to advance the complaint device over a 0.014 inch wire guide, and in doing so inadvertently kinked the complaint device.The device was caught on the 0.014 inch wire guide and the user was unable to advance or remove the complaint device.The user then removed the 0.014 inch wire guide and attempted to advance a 0.035 stiff glide wire through the ptx delivery system without success.At this point the user applied excessive force and the entire ptx delivery system was retracted back across the bifurcation and removed from the patient.Once the ptx delivery system was out of the patient, it was noted that the distal portion of the ptx stent system had separated, but remained in the sheath.At this point, the procedure was aborted.Images were provided to support the complaint investigation.These were reviewed through and the following comments were provided by the independent reviewer: findings: four images photographed off an angiography monitor are provided along with the complaint report; the images demonstrate a kinked ansel sheath in the right common through external iliac arteries containing a zilver ptx stent and distal tip.The proximal zilver stent was kinked at the sheath kink.The distal delivery sheath marker was till present while the distal stent stop was absent.Its absence reflects delivery inner cannula fracture along the stent; sheath undulation and narrowing at the kink point is consistent with stretching; the aortic bifurcation was steep, 42 degrees, and made even more acute by previous kissing stents extending at least to if not into the aorta; wire access had been lost in the unsuccessful attempt to straighten the kink with an amplatz extra stiff wire; the target lesion was likely the left sfa with treatment intended from a right contralateral approach.Impression: stent delivery system kink was not surprising given advancement was attempted over a 0.014 wire through a steep previously stented aortic bifurcation.The only system that would have possibly not kinked would have been an arrow super-flex with an extra or ultra-stiff.035 guide wire as recommended in the ifu.This may not have been possible even if tried.First, it can be difficult to advance an arrow super-flex sheath through stents.Second, use of a.014 wire suggests.035 wire advancement down the left iliac artery was not possible without reduction of the system into the aorta; the sheath stretched where it kinked.This likely also corresponded to where the delivery system fractured on forced removal.The stent sheath bound at this point to the damaged delivery sheath preventing removal; significant findings relative to the patient's anatomy were observed.The aortic bifurcation was acute and previously stented; significant findings relative to the disease state were not observed; significant findings relative to the use of the device were observed.The stent delivery system was advanced over a.014 wire through a steep previously stented iliac bifurcation; significant findings relative to the design or performance of the device were not observed.Based on the above, the complaint device became kinked when advancing the delivery system to the target location as the image review impression #1 states: ¿stent delivery system kink was not surprising given advancement was attempted over a 0.014 wire through a steep previously stented aortic bifurcation.¿.It can be noted that according to the instructions for use, the user is advised of the following: "to introduce a 0.89mm (0.035inch) wire guide" when using zisv6-35-125-6-120-ptx device.Based on the lab evaluation findings and available complaint information, the customer complaint has been confirmed.The advancement difficulties the user experienced was caused by the device kink.The point of the kink was also found to have stretched likely corresponding with the device fracture point upon forced removal of the device.The device kink was potentially caused by the advancement over a non indicated 0.014 inch wire guide in association with the difficult patient anatomy.However, as the conditions of device usage cannot be replicated in laboratory settings it is not possible to definitively state how the kink on the device occurred.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.Q.C.Inspectors are required to confirm that catheter lumen is open and free of blockages: ¿with the handle in the handle nest, insert a wire guide through the bushing of the handle nest and flla of the system.Pass the wire through until it exits at the tip.Fully remove the wire guide from the system.If there is difficulty passing the wire guide through the system, reject the unit.Any issues would have been noticed during this inspection.According to the complaint information, ¿a section of the device did not remain inside the patient¿s body.A closure device was used as the procedure needed to be aborted.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence¿.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

This follow up report is being submitted due to the conclusion of the investigation relating to this event.Initial description submitted as follows: the patient had a tight bifurcation.A g56231 was advanced over the bifurcation.Ptx delivery system was placed over a.014 wire; upon advancing over the bifurcation, the ptx delivery system kinked, not allowing advancement or removal of the system at this point the physician removed the.014 wire and tried to advance a.035 stiff glide wire through ptx delivery system without success and removed the wire.The physician tried to advance an amplantz extra stiff wire through ptx delivery system without success and removed the wire.At this point the entire ptx delivery system was retracted back across the bifurcation.Excessive force was needed to remove the ptx delivery system.Once the ptx delivery system was out of the patient, it was noted that the distal potion of the ptx stent system had separated/broken off, but remained in the sheath.At this point, the procedure was aborted.The physician cut the g56231 and advanced a 8.0 10cm teurmo sheath over the g56231 in order to use closure device.

• 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
• Manufacturer Contact: sinead quaid ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 5706193
• MDR Text Key: 46800132
• Report Number: 3001845648-2016-00152
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384825
• UDI-Public: (01)10827002384825(17)170205(10)C1212390
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-6-120-PTX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/13/2016
• Event Location: Hospital
• Date Manufacturer Received: 05/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2016
• 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 Age: 74 YR
• Patient Weight: 91