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

Model Number G38479

Device Problems Fracture (1260); Structural Problem (2506)

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

Event Type  Injury  

Event Description

Reported by the dm via phone call the physician did a routine follow up on the patient, during the ultrasound it was discovered he device was fractured in half.The physician has intentions to cover with a new covered stent.The following has been answered: (b)(6), (b)(6) 2022.Did any unintended section of the device remain inside the patient¿s body? no.If yes, please describe.Did the patient require any additional procedures due to this occurrence? not yet.Did the product cause or contribute to the need for additional procedures? yes.If yes, please specify additional procedures and provide details.Additional procedure information is not available currently.Has the complainant reported any adverse effects on the patient due to this occurrence? no.Has the complainant reported that the product caused or contributed to the adverse effects? no.Please specify adverse effects and provide details.Was the patient hospitalized or was there prolonged hospitalization due this occurrence? no.

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

Supplemental report is being submitted due to the imaging review completed on 02-mar-2022: impression: the provided image confirms a type iii zisv6-35-125-6-60-ptx stent fracture.The sfa segment was aneurysmal around and beyond at least one end of the stent.This aligns with ae assessment.Follow up mdr scheduled to caoture imaging review.

Manufacturer Narrative

Pma/510(k) # p100022/s014.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

Pma/510(k)#: p100022/s014.Device evaluation: the zisv6-35-125-6-60-ptx device of lot number: c1573052 involved in this complaint was implanted in the patient and not available for evaluation.With the information provided, a document-based investigation was conducted.Document review: prior to distribution zisv6-35-125-6-80-ptx devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl a review of the manufacturing records for zisv6-35-125-6-60-ptx of lot number: c1573052 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has or has not previously occurred with the current lot number.Based on the information available to date, there is or there is no evidence to suggest that there are any manufacturing issues associated with lot number: c1573052.It should be noted that stent strut fracture is listed as a known potential adverse event within the instructions for use (ifu0118).There is no evidence to suggest the user did not follow the ifu.Image review: images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer.Impression: the provided image confirms a type iii zisv6-35-125-6-60-ptx stent fracture.The sfa segment was aneurysmal around and beyond at least one end of the stent.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to stent fatigue.From the information provided it is known that the stent was in place since 2019.The patient¿s pre-existing conditions are not known but it is possible that excessive force from a difficult patient anatomy may have also caused and/or contributed to the stent fracture.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the physician will now need to do an additional surgery to cover the fractured stent.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 28-june-2022.

• 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: 13578290
• MDR Text Key: 291707067
• Report Number: 3001845648-2022-00101
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384795
• UDI-Public: (01)10827002384795(17)201011(10)C1573052
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2020
• Device Model Number: G38479
• Device Catalogue Number: ZISV6-35-125-6-60-PTX
• Device Lot Number: C1573052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2019
• 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: 68 YR
• Patient Sex: Male