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

Model Number G24935

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/15/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: p100022/s001.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

12-004 - study pt, site reported fracture of study stent one.Two zilver® ptx® v study stents were deployed during the index procedure on (b)(6) 2014.The study lesion was the left distal sfa.The study lesion was 120 mm long with 100% diameter stenosis, moderate calcification and no thrombus.The proximal reference vessel diameter (rvd) was 6.5 mm and the distal rvd was 5.5 mm.There was one patent runoff vessel.Entry site was contralateral.Pre-stent dilatation was performed with one inflation of a 5 mm x 140 mm balloon.The two study stents were deployed without difficulty.Post-stent dilatation was performed with one inflation of a 6 mm x 100 mm balloon.Final angiography measurements revealed 0 % residual stenosis in the study lesion.There was no thrombus or dissection and the entire length of the stents were apposed to the vessel wall.The patient was discharged on 05/13/2014 (one day post-procedure), taking aspirin and plavix.The 12-month x-ray was not performed.On (b)(6) 2019 (1890 days post-procedure), the study clinical assessment and imaging were completed.Per the site, study stent 1 had a type 1 fracture located in the mid-section of the stent.No fracture is noted of study stent 2.There is no clinical sequelae noted.Core lab analysis is not yet available.Fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent fracture'.No adverse effects to the patient have been reported as occurring.

Event Description

12-004 - study pt, site reported fracture of study stent one.Two zilver® ptx® v study stents were deployed during the index procedure on (b)(6) 2014.The study lesion was the left distal sfa.The study lesion was 120 mm long with 100% diameter stenosis, moderate calcification and no thrombus.The proximal reference vessel diameter (rvd) was 6.5 mm and the distal rvd was 5.5 mm.There was one patent runoff vessel.Entry site was contralateral.Pre-stent dilatation was performed with one inflation of a 5 mm x 140 mm balloon.The two study stents were deployed without difficulty.Post-stent dilatation was performed with one inflation of a 6 mm x 100 mm balloon.Final angiography measurements revealed 0 % residual stenosis in the study lesion.There was no thrombus or dissection and the entire length of the stents were apposed to the vessel wall.The patient was discharged on (b)(6) 2014 (one day post-procedure), taking aspirin and plavix.The 12-month x-ray was not performed.On (b)(6) 2019 (1890 days post-procedure), the study clinical assessment and imaging were completed.Per the site, study stent 1 had a type 1 fracture located in the mid-section of the stent.No fracture is noted of study stent 2.There is no clinical sequelae noted.Core lab analysis is not yet available.Fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent fracture'.No adverse effects to the patient have been reported as occurring.

Manufacturer Narrative

Pma/510(k) #: p100022/s001.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

12-004 - study pt, site reported fracture of study stent one.Two zilver® ptx® v study stents were deployed during the index procedure on (b)(6) 2014.The study lesion was the left distal sfa.The study lesion was 120 mm long with 100% diameter stenosis, moderate calcification and no thrombus.The proximal reference vessel diameter (rvd) was 6.5 mm and the distal rvd was 5.5 mm.There was one patent runoff vessel.Entry site was contralateral.Pre-stent dilatation was performed with one inflation of a 5 mm x 140 mm balloon.The two study stents were deployed without difficulty.Post-stent dilatation was performed with one inflation of a 6 mm x 100 mm balloon.Final angiography measurements revealed 0 % residual stenosis in the study lesion.There was no thrombus or dissection and the entire length of the stents were apposed to the vessel wall.The patient was discharged on (b)(6) 2014 (one day post-procedure), taking aspirin and plavix.The 12-month x-ray was not performed.On (b)(6) 2019 (1890 days post-procedure), the study clinical assessment and imaging were completed.Per the site, study stent 1 had a type 1 fracture located in the mid-section of the stent.No fracture is noted of study stent 2.There is no clinical sequelae noted.Core lab analysis is not yet available.(b)(6) 2020 core lab assessment indicates study stent number 1 has a type 3 fracture in stent segment 4.Study stent 2 has a type 1 fracture in stent segment 9.There is no stent deformation or changes in pattern type of either stent.No clinical sequelae was noted.Additional file opened to capture second stent fracture.

Manufacturer Narrative

Pma/510(k) #: p100022/s001.Additional information: core lab analysis has confirmed fracture of stent 2.Additional file opened.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

12-004 - study pt, site reported fracture of study stent one.Two zilver® ptx® v study stents were deployed during the index procedure on (b)(6) 2014.The study lesion was the left distal sfa.The study lesion was 120 mm long with 100% diameter stenosis, moderate calcification and no thrombus.The proximal reference vessel diameter (rvd) was 6.5 mm and the distal rvd was 5.5 mm.There was one patent runoff vessel.Entry site was contralateral.Pre-stent dilatation was performed with one inflation of a 5 mm x 140 mm balloon.The two study stents were deployed without difficulty.Post-stent dilatation was performed with one inflation of a 6 mm x 100 mm balloon.Final angiography measurements revealed 0 % residual stenosis in the study lesion.There was no thrombus or dissection and the entire length of the stents were apposed to the vessel wall.The patient was discharged on (b)(6) 2014 (one day post-procedure), taking aspirin and plavix.The 12-month x-ray was not performed.On (b)(6) 2019 (1890 days post-procedure), the study clinical assessment and imaging were completed.Per the site, study stent 1 had a type 1 fracture located in the mid-section of the stent.No fracture is noted of study stent 2.There is no clinical sequelae noted.Core lab analysis is not yet available.

Manufacturer Narrative

Pma/510(k) #: p100022/s001.Device evaluation this file is related to (b)(4).This file captures the type iii stent fracture in the distal stent (study stent one) and (b)(4)captures the type ii fracture in the distal end of the proximal stent (study stent two).The ziv6-35-125-6-100-ptx device of lot number c975166 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: prior to distribution ziv6-35-125-6-100-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 ziv6-35-125-6-100-ptx of lot number c975166 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current 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 c975166.It should be noted that the instructions for use (ifu0093-5) states the following: ¿indications for use the zilver ptx drug-eluting stent in indicated for improving luminal diameter for the treatment of de novo or restenotic symptomatic lesions in native vascular disease of the above-the-knee femoropopliteal arteries having reference vessel diameter from 4 mm to 7 mm and total lesion lengths up to 140 mm per limb and 280 mm per patient.¿ there is evidence to suggest the user did not follow the ifu.From the information provided it is known that stent one was implanted through the p1 and p2 segments of the knee.This meant that the stent spanned from the distal sfa to the knee joint.The p2 segment of the knee is considered below the knee and outside of the indicated use of the device.It is likely that this resulted in the stent becoming fatigued due to knee flexion and fracturing.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.A type 3 fracture of the distal ziv6-35-125-6-100-ptx superior end at 60 months is confirmed.This likely represented the type 1 fracture that was the subject of the complaint report.2.A type 2 fracture of the proximal ziv6-35-125-6-100-ptx inferior end at 60 months is confirmed.3.The stented sfa and pa segment was severely calcified.Root cause review: a definitive root cause could be attributed to off-label use of the device.From the information provided it is known that stent one was implanted through the p1 and p2 segments of the knee.This meant that the stent spanned from the distal sfa to the knee joint.The p2 segment of the knee is considered below the knee and outside of the indicated use of the device.It is likely that this resulted in the stent becoming fatigued due to knee flexion and fracturing.Summary: complaint is confirmed as the failure was verified in the image(s).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 Description

12-004 - study pt, site reported fracture of study stent one.Two zilver® ptx® v study stents were deployed during the index procedure on (b)(6) 2014.The study lesion was the left distal sfa.The study lesion was 120 mm long with 100% diameter stenosis, moderate calcification and no thrombus.The proximal reference vessel diameter (rvd) was 6.5 mm and the distal rvd was 5.5 mm.There was one patent runoff vessel.Entry site was contralateral.Pre-stent dilatation was performed with one inflation of a 5 mm x 140 mm balloon.The two study stents were deployed without difficulty.Post-stent dilatation was performed with one inflation of a 6 mm x 100 mm balloon.Final angiography measurements revealed 0 % residual stenosis in the study lesion.There was no thrombus or dissection and the entire length of the stents were apposed to the vessel wall.The patient was discharged on (b)(6) 2014 (one day post-procedure), taking aspirin and plavix.The 12-month x-ray was not performed.On (b)(6) 2019 (1890 days post-procedure), the study clinical assessment and imaging were completed.Per the site, study stent 1 had a type 1 fracture located in the mid-section of the stent.No fracture is noted of study stent 2.There is no clinical sequelae noted.Core lab analysis is not yet available.On (b)(6) 2020 core lab assessment indicates study stent number 1 has a type 3 fracture in stent segment 4.Study stent 2 has a type 1 fracture in stent segment 9.There is no stent deformation or changes in pattern type of either stent.No clinical sequelae was noted.Additional file opened to capture second stent fracture.

Manufacturer Narrative

Pma/510(k) #: p100022/s001.Device evaluation: this file is related to (b)(4).This file captures the type iii stent fracture in the distal stent (study stent one) and (b)(4)captures the type ii fracture in the distal end of the proximal stent (study stent two).The ziv6-35-125-6-100-ptx device of lot number c975166 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: prior to distribution ziv6-35-125-6-100-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 ziv6-35-125-6-100-ptx of lot number c975166 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current 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 c975166.It should be noted that the instructions for use (ifu0093-5) states the following: ¿indications for use the zilver ptx drug-eluting stent in indicated for improving luminal diameter for the treatment of de novo or restenotic symptomatic lesions in native vascular disease of the above-the-knee femoropopliteal arteries having reference vessel diameter from 4 mm to 7 mm and total lesion lengths up to 140 mm per limb and 280 mm per patient.¿ there is evidence to suggest the user did not follow the ifu.From the information provided it is known that stent one was implanted through the p1 and p2 segments of the knee.This meant that the stent spanned from the distal sfa to the knee joint.The p2 segment of the knee is considered below the knee and outside of the indicated use of the device.It is likely that this resulted in the stent becoming fatigued due to knee flexion and fracturing.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 (ref att.(b)(4)imaging review ver1'): impression 1.A type 3 fracture of the distal ziv6-35-125-6-100-ptx at 60 months is confirmed.2.A type 2 fracture of the distal ziv6-35-125-6-100-ptx at 60 months is confirmed.3.The stented sfa and pa segment was severely calcified.Root cause review: a definitive root cause could be attributed to off-label use of the device.From the information provided it is known that stent one was implanted through the p1 and p2 segments of the knee.This meant that the stent spanned from the distal sfa to the knee joint.The p2 segment of the knee is considered below the knee and outside of the indicated use of the device.It is likely that this resulted in the stent becoming fatigued due to knee flexion and fracturing.Summary: complaint is confirmed as the failure was verified in the image(s).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.

• 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
• MDR Report Key: 9390230
• MDR Text Key: 168585726
• Report Number: 3001845648-2019-00636
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002249353
• UDI-Public: (01)10827002249353(17)150114(10)C975166
• 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: 03/23/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2015
• Device Model Number: G24935
• Device Catalogue Number: ZIV6-35-125-6-100-PTX
• Device Lot Number: C975166
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/15/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 11/28/2019
• Supplement Dates Manufacturer Received: 11/04/2019; 11/04/2019; 11/04/2019; 11/04/2019
• Supplement Dates FDA Received: 12/24/2019; 02/14/2020; 03/13/2020; 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR