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

Catalog Number UNKNOWN

Device Problems Off-Label Use (1494); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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

As reported by the dm matthew mccommon via phone conversation (covering form rachel propst) "device placed in the external iliac and it migrated approx.4cm.They used a stiff.035 wire.The physician did not pre-dilate the lesion, but the physician did post-dilate and gained good wall-apposition.Over the stiff.035 wire, the physician inserted the inner 6fr ansel over the stiff wire - at this point the physician tried to advance the 6fr sheath through the stent (and the sheath and dilator got stuck on the mid-section of the stent).It then dislodged and migrated approx.4 cm's.At this point, the physician backed-up the sheath because she could not get the sheath all the way through.Thus, the physician backed-out the sheath and rotated it and then re-advanced the sheath.At this point the physician was able to get through the stent.She re-ballooned the stent where it landed and then re-ballooned the original segment (where she was trying to treat with the stent).The physician elected to leave the stent where it is currently located." per dm complaint email "i need to issue a product complaint on behalf of dr.(b)(6), (b)(6), (b)(4), who deployed an 8 mm zilver ptx stent and then tried to drive her sheath through the stent, which ended up with the stent migrating.No fractures occurred." did any unintended section of the device remain inside the patient¿s body? - no please describe the object and how it was retrieved: did the patient experience a delay or require any additional procedure due to this occurrence? - per dm, see above event description.Please specify delay or any additional procedure(s) and provide details: has the complainant reported any adverse effects on the patient due to this occurrence? - none reported to the dm has the complainant reported that the product caused or contributed to the adverse effects? - none reported to the dm please specify adverse effects and provide details.Any manufacture additional questions will be determined when the gpn / rpn is provided.-rf 12apr2022.

Event Description

Final mdr being submitted due to confirmtion of off-label use on 17-may-2022 and subsequent completion of the investigation.

Manufacturer Narrative

Device evaluation the zisv6 device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Document review as the zisv6 and lot number of the complaint stents is unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all zisv6 devices are subject to visual a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl it should be noted that the instructions for use (ifu0117) states the following: ¿¿ the zilver ptx drug-eluting peripheral stent is intended for use in the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal arteries¿¿ there is evidence to suggest the user did not follow the ifu.Root cause review a definitive root cause off label use was identified.From the available information it is known that the stent was placed in the external iliac artery.Summary the complaint is confirmed based on customer testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The physician elected to leave the stent where it is currently located.Complaints of this nature will continue to be monitored for potential emerging trends.

Manufacturer Narrative

Device evaluation: the zisv6 device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Document review: as the zisv6 and lot number of the complaint stents is unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all zisv6 devices are subject to visual a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.It should be noted that the instructions for use (ifu0117) states the following: ¿¿ the zilver ptx drug-eluting peripheral stent is intended for use in the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal arteries¿¿ there is evidence to suggest the user did not follow the ifu.Root cause review a definitive root cause off label use was identified.From the available information it is known that the stent was placed in the external iliac artery.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The physician elected to leave the stent where it is currently located.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Final mdr being submitted due to confirmation of off-label use on (b)(6) 2022 and subsequent completion of the investigation.

Event Description

Supplemental correction report is being submitted following a g code update from g04122 - stent to g07001 - part/component/sub-assembly term not applicable on 27-oct-2023.

Manufacturer Narrative

Supplemental correction report is being submitted following a g code update from g04122 - stent to g07001 - part/component/sub-assembly term not applicable on 27-oct-2023.Device evaluation: the zisv6 device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Document review: as the zisv6 and lot number of the complaint stents is unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all zisv6 devices are subject to visual a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.It should be noted that the instructions for use (ifu0117) states the following: ¿¿the zilver ptx drug-eluting peripheral stent is intended for use in the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal arteries¿¿ there is evidence to suggest the user did not follow the ifu.Root cause review: a definitive root cause off label use was identified.From the available information it is known that the stent was placed in the external iliac artery.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The physician elected to leave the stent where it is currently located.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 14344510
• MDR Text Key: 294681856
• Report Number: 3001845648-2022-00271
• 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: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• 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
• Event Location: Hospital
• Date Manufacturer Received: 10/13/2023
• 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