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

Catalog Number UNKNOWN

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Occlusion (1984); Restenosis (4576)

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: p050017/s006.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Description of event: milnerowicz-¿rotational atherectomy plus drug-coated balloon angioplasty for the treatment of total in-stent occlusions in iliac and infrainguinal arteries¿.Over 1 year (table 3), 15 (20.5%) of the 73 patients developed recurrent restenosis; 4 of these patients underwent revascularization of the target lesion.Recurrent restenosis happened significantly more often in patients with rutherford category 5 ischemia (71% vs 23% for category 4 vs 8% for category 3 vs 8% for category 2, p=0.005).It was also more common in emergency vs elective procedures (33% vs 11%, p=0.021) and after extensive procedures involving 3 anatomically independent vessel segments (50% vs 22% for 2 segments vs 7% for 1 segment, p=0.016).Fda mdr reporting required: this event meets the criteria of an fda ¿serious injury¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ section 2.13 and 2.15 as patients developed restenosis and required revascularization of the target lesion in 4 cases.

Event Description

The investigation was concluded on the 23-jul, this follow up mdr is being submitted to include the investigation conclusions.Description of event: milnerowicz-¿rotational atherectomy plus drug-coated balloon angioplasty for the treatment of total in-stent occlusions in iliac and infrainguinal arteries¿.Over 1 year (table 3), 15 (20.5%) of the 73 patients developed recurrent restenosis; 4 of these patients underwent revascularization of the target lesion.Recurrent restenosis happened significantly more often in patients with rutherford category 5 ischemia (71% vs 23% for category 4 vs 8% for category 3 vs 8% for category 2, p=0.005).It was also more common in emergency vs elective procedures (33% vs 11%, p=0.021) and after extensive procedures involving 3 anatomically independent vessel segments (50% vs 22% for 2 segments vs 7% for 1 segment, p=0.016).Fda mdr reporting required: this event meets the criteria of an fda ¿serious injury¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ section 2.13 and 2.15 as patients developed restenosis and required revascularization of the target lesion in 4 cases.

Manufacturer Narrative

Device evaluation: the zilver flex 35 vascular self-expanding stent device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.Lab evaluation: n/a-the device did not return.Document review : prior to distribution zilver flex 35 vascular self-expanding stent 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 there is no evidence to suggest that the customer did not follow the instructions for use (ifu0058).Restenosis of the stented artery is also listed as a known potential adverse event within 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 patient's pre-existing conditions.Restenosis of the stented artery is also listed as a known potential adverse event within the ifu and is a common adverse event of endovascular procedures that can be caused by injury to the vessel (e.G.During percutaneous transluminal angioplasty (pta) and/or stenting).Vessel injury provokes an inflammatory response that leads to or amplifies the restenosis process.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the patient did experience restenosis.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental follow-up correction report is being submitted due to the update to "description of event" and receipt of clinical input confirming off-label use resulting in an update to the investigation conclusions.Updated description of event: milnerowicz-¿rotational atherectomy plus drug-coated balloon angioplasty for the treatment of total in-stent occlusions in iliac and infrainguinal arteries¿.Over 1 year (table 3), 15 (20.5%) of the 73 patients developed recurrent restenosis; 4 of these patients underwent revascularization of the target lesion.Recurrent restenosis happened significantly more often in patients with rutherford category 5 ischemia (71% vs 23% for category 4 vs 8% for category 3 vs 8% for category 2, p=0.005).It was also more common in emergency vs elective procedures (33% vs 11%, p=0.021) and after extensive procedures involving 3 anatomically independent vessel segments (50% vs 22% for 2 segments vs 7% for 1 segment, p=0.016).Patient outcome: 73 patients developed recurrent restenosis.Note: this number was updated to 15 following review.

Manufacturer Narrative

Pma/510(k) #p050017/s006.The zilver flex 35 vascular self-expanding stent device (zfv6) of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Prior to distribution zilver flex 35 vascular self-expanding stent 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.There is evidence to suggest that the customer did not follow the instructions for use.Instructions for use state the following intended used the product is intended for use in the iliac, superficial femoral artery (sfa) and above the knee popliteal artery for the following treatments: arteriosclerotic stenosis, total occlusions that have been recanalized.Arterial stents are not indicated for stenting of a previously placed stent.According to the customer testimony the stents were used to treat in-stent restenosis.A definitive root cause of off label use was identified from the information available.According to the customer testimony the stents were used to treat in-stent restenosis.It is not possible to state how the device will perform when used outside of its validated state.The complaint is confirmed based on customer testimony.According to the initial reporter, the patient did experience restenosis.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: 9584921
• MDR Text Key: 189450598
• Report Number: 3001845648-2020-00024
• 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: literature
• Type of Report: Initial,Followup,Followup
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention