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

Model Number G38480

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 05/23/2018

Event Type  Injury  

Manufacturer Narrative

The 510(k) number: p100022/s014.(b)(4).(b)(4).Device evaluation: the zisv6-35-125-6-80-ptx device of lot number c1480754 involved in this complaint has not yet been returned for evaluation.With the information provided, a document based investigation was conducted.The investigation will be updated if and when the device has been returned and evaluated.There are three complaints related to this device.This complaint details the investigation for compression of the fourth stent.A guide stiff angle 0.035¿ wire guide was used during the procedure.The device was flushed as per the instructions for use (ifu).From customer testimony, it was confirmed that the target site was the superficial femoral artery (sfa) and was severely calcified/tortuous.The patient¿s leg was confirmed to have a lot of problems and was described as a ¿disaster¿.It is known that three ptx stents (g38483, lot# c1463524) of the same size (6x140) and lot number were implanted in the patient.A fourth stent (g38480, lot# c1480754) was also implanted.From customer testimony it is known that the user failed to use an access sheath during the complaint procedure.The stents did not fracture and was fully deployed.There is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.Possible root causes for this complaint could include difficult patient anatomy and not using an access sheath.Difficult patient anatomy could have caused of contributed to compression of the stent.It is possible that resistance (due to difficult patient anatomy) during advancement and/or deployment could have caused or contributed to compression of the stent.Not using an access sheath with the device may have caused longitudinal compression of the stent.From customer testimony ¿the difficulty was that the customer was placing the ptx in the patient through an open access, there was no sheath utilized.The customer did not hold tension on the deployment system above the transition point at the retraction portion of the deployment system.The result was the device drove forward and telescoped the stents¿.However, as the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.The instructions for use (ifu0118-3) states the following; ¿ensure the distal end of the stability sheath is inside the access sheath.¿ document review: prior to distribution all zisv6 devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1480754.Summary: there is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.The risk was determined to be low (category iii).According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This complaint is in relation to the fourth stent (g38480, lot# c1480754) that compressed.Reference report # 3001845648-2018-00423 for the remaining 3 stents.As reported to customer relations: "upon delivery of the stent, the distal tip fractured and came completely apart.Nothing left in patient.Procedure involved placing two 6x140s and one 6x80--another device was opened for the complaint device, and these three worked successfully.Additional information provided to dm by customer on 14aug2018: "the complaint from dr.(b)(6)¿s case is considered a reportable event and the investigation team has some additional questions.It has been a little while ago, so i wanted to reach out to confirm the details prior to responding to their request.Could you confirm if the ptx (g38483, lot # c1463524) was implanted in dr.(b)(6)¿s patient on (b)(6)? were any of the devices stuck on the wire guide during the procedure? if so, did it result in any of the products not being able to be deployed.Additionally, could you provide product g# and lot# for the other products that were implanted on (b)(6)? ----- yes, ptx g38483, lot# c1463524 was implanted.In fact, 3 of the same size and lot# were implanted.Three 6x140 stents with same lot#.The fourth stent was g38480, lot# c1480754." additional information provided by dm on 15aug2018: "i can confirm that none of the four stents implanted deployed at the length denoted on the packaging.The difficulty was that the customer was placing the ptx in the patient through an open access, there was no sheath utilized.The customer did not hold tension on the deployment system above the transition point at the retraction portion of the deployment system.The result was the device drove forward and telescoped the stents.All four implanted stents deployed at foreshortened lengths resulting in the physician placing 4 stents in the patient when he could have treated with 3 if the stents had not foreshortened.After being notified of this event, we re-educated the physician and staff regarding the best technique to utilize when deploying ptx through an open access.I hope this helps.Please let me know if you have any additional questions.".

• 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 (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: heather ryan ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 7868960
• MDR Text Key: 120243758
• Report Number: 3001845648-2018-00424
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384801
• UDI-Public: (01)10827002384801(17)191213(10)C1480754
• 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: Other
• Type of Report: Initial
• Report Date: 08/15/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2019
• Device Model Number: G38480
• Device Catalogue Number: ZISV6-35-125-6-80-PTX
• Device Lot Number: C1480754
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/15/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/16/2018
• Initial Date FDA Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2018
• 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: 71 YR