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

Catalog Number UNKNOWN

Device Problems Partial Blockage (1065); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stenosis (2263); Obstruction/Occlusion (2422); Restenosis (4576)

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) # p100022/s027.Date of event: between (b)(6) 2009 and (b)(6) 2014.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Meng et al 2018 (zilver ptx and flex) - "real-world comparison of drug-eluting and bare-metal stents in superficial femoral artery occlusive disease with trans-atlantic intersociety consensus b lesions: a 2-year, single-institute study".The routine procedure started from a contra-lateral retrograde or ipsilateral antegrade femoral punc-ture, according to the patients¿ anatomy and lesion site.Predilatation was always performed using a 3-4-mm diameter balloon before stenting.Simi-larly, postdilatation was always performed using a com-pliant balloon with either the same diameter or 1 mm less than the implanted stent diameter.Btk angioplasty was also performed if required.After completion of the angiography, the access sheath was removed and the punctured arteriotomy was manually compressed or re-paired using a vascular closure device.In-stent restenosis.Require intervention/additional procedures.

Manufacturer Narrative

Pma/510(k) #: p050017/s006.Annex g: g04122 - stent.Device evaluation: the zfv6 device of unknown rpn and 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 rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution zfv6 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.It should be noted that restenosis of the stented artery is listed as a known potential adverse event within the instructions for use (ifu0058-4).There is no evidence to suggest the user did not follow the ifu.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to difficult patient anatomy and/or the stent itself.From the available information it is known that patient pre-existing conditions included hypertension, diabetes mellitus, hyperlipidemia, chronic obstructive pulmonary disorder (copd) and coronary artery disease (cad).It is possible that patient pre-existing conditions caused and/or contributed to the events of restenosis requiring additional intervention and/or procedures.As mentioned above restenosis of the stented artery is listed as a known potential adverse event within the ifu.However, there is no evidence within the journal article to suggest any device malfunction or deterioration in device characteristics.Summary the complaint is confirmed based on customer testimony.According to the initial reporter 16 patients developed in-stent restenosis.Patient outcomes are unknown but clinical input suggests that restenosis would likely have required some form of intervention or additional procedure.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report being submitted to update device name (22-feb-2021) and completion of the investigation on 26-feb-2021.Meng et al 2018 (zilver ptx and flex) - "real-world comparison of drug-eluting and bare-metal stents in superficial femoral artery occlusive disease with trans-atlantic intersociety consensus b lesions: a 2-year, single-institute study".The routine procedure started from a contra-lateral retrograde or ipsilateral antegrade femoral punc-ture, according to the patients¿ anatomy and lesion site.Predilatation was always performed using a 3-4-mm diameter balloon before stenting.Simi-larly, postdilatation was always performed using a com-pliant balloon with either the same diameter or 1 mm less than the implanted stent diameter.Btk angioplasty was also performed if required.After completion of the angiography, the access sheath was removed and the punctured arteriotomy was manually compressed or re-paired using a vascular closure device.In-stent restenosis.Require intervention/additional procedures.

Event Description

Supplemental report being submitted to update e code from e2328 - obstruction/occlusion to e233701 - restenosis.Change was confirmed on (b)(6) 2021.

Manufacturer Narrative

Pma/510(k) #: p050017/s006.Device evaluation: the zfv6 device of unknown rpn and 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 rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution zfv6 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 it should be noted that restenosis of the stented artery is listed as a known potential adverse event within the instructions for use (ifu0058-4).There is no evidence to suggest the user did not follow the ifu.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to difficult patient anatomy and/or the stent itself.From the available information it is known that patient pre-existing conditions included hypertension, diabetes mellitus, hyperlipidemia, chronic obstructive pulmonary disorder (copd) and coronary artery disease (cad).It is possible that patient pre-existing conditions caused and/or contributed to the events of restenosis requiring additional intervention and/or procedures.As mentioned above restenosis of the stented artery is listed as a known potential adverse event within the ifu.However, there is no evidence within the journal article to suggest any device malfunction or deterioration in device characteristics.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter 16 patients developed in-stent restenosis.Patient outcomes are unknown but clinical input suggests that restenosis would likely have required some form of intervention or additional procedure.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT
• Type of Device: NIO STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10242688
• MDR Text Key: 197931474
• Report Number: 3001845648-2020-00405
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/17/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 07/07/2020
• Supplement Dates Manufacturer Received: 07/01/2021; 07/01/2020
• Supplement Dates FDA Received: 03/10/2021; 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR