MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT; NIO STENT, ILIAC

Catalog Number	ZFV6-35-80-7-40
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	02/02/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: p050017/s006.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
On (b)(6) 2012: zfv6-35-80-7-40 (c773053) was placed on the patient's left upper sfa.On (b)(6) 2013: type i stent fracture at the middle of the flex stent was observed by the x-ray.Additional treatment against fracture was not performed.At five years follow up: it was performed the assessment of left leg.Wait-and-see approach was taken.There was no observation of worsen stent fracture.[note from (b)(6)]: this patient has been treated with 1x flex on upper fsa and 2x ptx on lower sfa with overlap.When ptx stent fracture was reported, the physician confound ptx and flx and was absent to report.Additional treatment against fracture was not performed.The image will not be available.There was no vessel tortuousity.
Additional Manufacturer Narrative
Pma/510(k) #: p050017/s006.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4).Cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Note: there are two additional files (b)(4) and (b)(4) related to this complaint.Device evaluation: the zfv6-35-80-7-40 device of lot number c773053 involved in this complaint was implanted in the patient, and was not available for evaluation.With the information provided, a document based investigation was conducted.Lab evaluation: n/a.Document review: prior to distribution zfv6-35-80-7-40 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 relevant manufacturing records (c773053) 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 c773053.There is no evidence to suggest that the customer did not follow the instructions for use.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient pre-existing conditions.From the available information it is known that the patient had a medical history of hypertension, carotid disease, hypercholesterolemia, diabetes(type ii) and coronary artery disease.It is possible that the aforementioned medical conditions may have exerted excessive force on the stent possibly causing a stent fracture.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.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
1 aug 2012:zfv6-35-80-7-40 (c773053) was placed on the patient's left upper sfa.(b)(6) 2013:type i stent fracture at the middle of the flex stent was observed by the x-ray.Additional treatment against fracture was not performed.At five years follow up: it was performed the assessment of left leg.Wait-and-see approach was taken.There was no observation of worsen stent fracture.[note from ca/cj]: this patient has been treated with 1x flex on upper fsa and 2x ptx on lower sfa with overlap.When ptx stent flacture was reported, the physician confound ptx and flx and was absent to report.Additional treatment against fracture was not performed the image will not be available.There was no vessel tortuousy.

• Brand Name: ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT
• Common Device Name: NIO STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8771352
• Report Number: 3001845648-2019-00311
• Device Sequence Number: 13875651
• Product Code: NIO
• UDI-Device Identifier: 10827002182391
• UDI-Public: (01)10827002182391(17)150612(10)C773053
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2015
• Device Catalogue Number: ZFV6-35-80-7-40
• Device Lot Number: C773053
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/09/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 08/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR