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

Catalog Number UNKNOWN

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombus (2101)

Event Date 10/04/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Two 7 mm zilver ptx stents were placed in the patient in 2015.During a post thrombolysis, it was noted that there was flow behind the stent struts and also stent fractures.Drip tpa was administered to dissolve the clot, and a and a 7 x 250 gore viabahn covered stent was placed.The patient outcome was noted to be stable/good.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 the patient required an additional stent placement also reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent fracture'.

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Two 7mm zilver ptx stents were placed in the patient in 2015.During a post thrombolysis, it was noted that there was flow behind the stent struts and also stent fractures.Drip tpa was administered to dissolve the clot, and a and a 7 x 250 gore viabahn covered stent was placed.The patient outcome was noted to be stable/good.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 the patient required an additional stent placement also reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent fracture'.

Event Description

Two 7mm zilver ptx stents were placed in the patient in 2015.During a post thrombolysis, it was noted that there was flow behind the stent struts and also stent fractures.Drip tpa was administered to dissolve the clot, and a and a 7 x 250 gore viabahn covered stent was placed.The patient outcome was noted to be stable/good.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 the patient required an additional stent placement also reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent fracture'.

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Follow up report is being submitted to update the reporting rationale below.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 drip tpa was administered to dissolve the clot also reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent fracture'.

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

Device evaluation the zisv6 device of unknown lot number 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.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 zisv6 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 the instructions for use (ifu0118-5) lists arterial thrombosis as a known potential adverse event.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 1.Stent fracture is confirmed.Type i fractures developed right inferior side of both 7mm stents between one and four years.The fractures were not associated with lumen stenosis or nih.2.Space between the stents and the artery wall consistent with peri-stent staining is confirmed.Although it may have developed after one year, it also may have just been uncovered by the 36-hour tpa infusion.Although commonplace in the past, infusions lasting more than one day are now usually unnecessary with more effective atherectomy/embolectomy devices.Peri-stent staining has been reported at 20 months post zilver ptx implantation (ann vasc dis.2018 sep 25; 11(3): 373¿376.).3.The 50% stenosis from nih in the superior most 6x80mm stent was insufficient to cause thrombosis.Root cause review a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.From the information provided it is known that the patient underwent 36-hour drip tpa to treat thrombosis, a known potential adverse event within the ifu.Based on the clinical input received from this file it is known that the drip tpa was administered as a secondary intervention to treat thrombosis.It is likely that the drip tpa caused stent malapposition which in turn led to the blood flow behind the stents.In summary, a possible root cause could be attributed to stent malapposition as a result of the 36-hour drip tpa infusion administered to the patient to dissolve a blood clot.Summary complaint is confirmed as the failure was verified in the image(s).According to the initial reporter, the patient¿s outcome was noted to be stable/good.It is known that the entire stented segment was lined with a viabahn stent.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Two 7mm zilver ptx stents were placed in the patient in 2015.During a post thrombolysis, it was noted that there was flow behind the stent struts pr(b)(6) and also stent fractures pr(b(4) and pr (b)(4).Drip tpa was administered to dissolve the clot, and a and a 7 x 250 gore viabahn covered stent was placed.The patient outcome was noted to be stable/good.Imaging review determined a type 1 stent fracture unrelated to blood flow behind stents.Imaging review confirmed restenosis.Pr(b)(4).

• Brand Name: ZILVER PTX DRUG ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9265404
• MDR Text Key: 165641761
• Report Number: 3001845648-2019-00578
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• PMA/PMN Number: P100022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/04/2019
• Event Location: Hospital
• Date Manufacturer Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 78