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 Off-Label Use (1494); Failure to Shut Off (2939)

Patient Problems Thrombosis (2100); No Known Impact Or Consequence To Patient (2692); Thrombosis/Thrombus (4440)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Statement below is extracted from the attached article "imai - pathological findings of late total occlusion after zilver ptx stent.Pdf".A (b)(6) year-old man developed lower limb ischemia treating after underwent left femoropopliteal bypass (fp bypass) surgery for treatment of left superficial femoral artery (sfa) total occlusion.One year later, since the fp bypass graft was becoming totally occluded, recanalization was attempted using endovascular therapy (evt).Bare-metal nitinol stent (bns) of two smart stents (cordis, miami, fl; 7.0 x 120 mm, 6.0 x 150 mm) and one misago stent (terumo, (b)(4); 7.0 x 60 mm) were deployed to cover the entire lesion (fig.1a).The patient was discharged with prescriptions for oral anticoagulant (warfarin) and antiplatelet agents (aspirin 100 mg, clopidogrel 75 mg).At 9 months after first evt, angiography showed total occlusion of the left sfa.Four zilver ptx stents; paclitaxel-coated stent (pcs) (cook medical, (b)(4); 7.0 x 60 mm, 7.0 x 100 mm, 7.0 x 100 mm, 7.0 x 100 mm) were deployed to cover all lesions with bns and one express stent (7.0 x 27 mm) was interpolated for under expansion lesion of pcs (fig.1a).Six months after second evt, due to progressive limb ischemia, above-the-knee amputation of the left limb was performed and the specimen harvested.Microscopic observation revealed massive thrombus formation, mainly on the luminal side of the stent struts (fig.1b).Existing neointimal tissue exhibited remarkable shedding and disappearance from the luminal surface of the pcs and most of which consisted of amorphous necrotic tissue (fig.1b, c).Nuclear ghosts were scattered among amorphous material consisting of necrotic tissue and fibrin components (fig.1d).

Manufacturer Narrative

Device evaluation: this file relates to (b)(4).This file was opened to capture off-label use of the zilver ptx stents as they were used to re-stent existing nitinol stents.(b)(4) investigates late stent thrombosis.The unknown zisv6 device of unknown 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 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 (ifu0117-4) includes instructions for placing stents in an overlapping manner.It does not contain information regarding re-stenting of a previously placed nitinol stent.There is evidence to suggest that the customer did not follow the ifu.The japanese packaging insert ((b)(6)) supplied with the device complies with mhlw law no.84 of 2013 which avoids including information that is not specific to the medical device or that which is basic knowledge already understood by the healthcare professional, to ensure to accurately convey all the information that is important for the user.Root cause review: a definitive root cause of the user not reading or following the ifu could be attributed to this complaint.The ifu does not contain instructions for re-stenting existing nitinol stents and so this is considered off-label use.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 Description

*statement below is extracted from the attached article "imai - pathological findings of late total occlusion after zilver ptx stent.Pdf".A 73-year-old man developed lower limb ischemia treating after underwent left femoropopliteal bypass (fp bypass) surgery for treatment of left superficial femoral artery (sfa) total occlusion.One year later, since the fp bypass graft was becoming totally occluded, recanalization was attempted using endovascular therapy (evt).Bare-metal nitinol stent (bns) of two smart stents (cordis, miami, fl; 7.0 × 120 mm, 6.0 × 150 mm) and one misago stent (terumo, tokyo, japan; 7.0 × 60 mm) were deployed to cover the entire lesion (fig.1a).The patient was discharged with prescriptions for oral anticoagulant (warfarin) and antiplatelet agents (aspirin 100 mg, clopidogrel 75 mg).At 9 months after first evt, angiography showed total occlusion of the left sfa.Four zilver ptx stents; paclitaxel-coated stent (pcs) (cook medical, bloomington, indiana; 7.0 × 60 mm, 7.0 × 100 mm, 7.0 × 100 mm, 7.0 × 100 mm) were deployed to cover all lesions with bns and one express stent (7.0 × 27 mm) was interpolated for under expansion lesion of pcs (fig.1a).Six months after second evt, due to progressive limb ischemia, above-the-knee amputation of the left limb was performed and the specimen harvested.Microscopic observation revealed massive thrombus formation, mainly on the luminal side of the stent struts (fig.1b).Existing neointimal tissue exhibited remarkable shedding and disappearance from the luminal surface of the pcs and most of which consisted of amorphous necrotic tissue (fig.1b, c).Nuclear ghosts were scattered among amorphous material consisting of necrotic tissue and fibrin components (fig.1d).

Event Description

Correction report being submitted due to below updates being made to the file, updates reviewed on (b)(6) 2021.G code updated from g04113 to g0701, annex e and f codes updated to reflect thrombosis (e0514) and amputation (f1902) as a result of this event.Imai - pathological findings of late total occlusion after zilver ptx stent.A 73-year-old man developed lower limb ischemia treating after underwent left femoropopliteal bypass (fp bypass) surgery for treatment of left superficial femoral artery (sfa) total occlusion.One year later, since the fp bypass graft was becoming totally occluded, recanalization was attempted using endovascular therapy (evt).Bare-metal nitinol stent (bns) of two smart stents (cordis, miami, fl; 7.0 × 120 mm, 6.0 × 150 mm) and one misago stent (terumo, tokyo, japan; 7.0 × 60 mm) were deployed to cover the entire lesion (fig.1a).The patient was discharged with prescriptions for oral anticoagulant (warfarin) and antiplatelet agents (aspirin 100 mg, clopidogrel 75 mg).At 9 months after first evt, angiography showed total occlusion of the left sfa.Four zilver ptx stents; paclitaxel-coated stent (pcs) (cook medical, bloomington, indiana; 7.0 × 60 mm, 7.0 × 100 mm, 7.0 × 100 mm, 7.0 × 100 mm) were deployed to cover all lesions with bns and one express stent (7.0 × 27 mm) was interpolated for under expansion lesion of pcs (fig.1a).Six months after second evt, due to progressive limb ischemia, above-the-knee amputation of the left limb was performed and the specimen harvested.Microscopic observation revealed massive thrombus formation, mainly on the luminal side of the stent struts (fig.1b).Existing neointimal tissue exhibited remarkable shedding and disappearance from the luminal surface of the pcs and most of which consisted of amorphous necrotic tissue (fig.1b, c).Nuclear ghosts were scattered among amorphous material consisting of necrotic tissue and fibrin components (fig.1d).

Manufacturer Narrative

Correction report being submitted due to below updates being made to the file, updates reviewed on 23-feb-2021.G code updated from g04113 to g0701, annex e and f codes updated to reflect thrombosis (e0514) and amputation (f1902) as a result of this event.

Manufacturer Narrative

Device evaluation: this file was opened to capture off-label use of the zilver ptx stents as they were used to re-stent existing nitinol stents and thrombosis.The unknown zisv6 device of unknown 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 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 (ifu0117-5) includes instructions for placing stents in an overlapping manner.It does not contain information regarding re-stenting of a previously placed nitinol stent.It should also be noted that arterial thrombosis is listed as a known potential adverse event within the ifu.There is evidence to suggest that the customer did not follow the ifu.The japanese packaging insert (c-ci1502m02) supplied with the device complies with mhlw law no.84 of 2013 which avoids including information that is not specific to the medical device or that which is basic knowledge already understood by the healthcare professional, to ensure to accurately convey all the information that is important for the user.Root cause review: a definitive root cause of the user not reading or following the ifu could be attributed to this complaint.The ifu does not contain instructions for re-stenting existing nitinol stents and so this is considered off-label use.The off-label use of the device may also have contributed to the reported stent thrombosis.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 Description

Supplemental report submitted to update report to capture the off label use of the device and subsequent patient condition related event (late stent thrombosis) based on medical input received 10-dec-2020.Imai - pathological findings of late total occlusion after zilver ptx stent.A 73-year-old man developed lower limb ischemia treating after underwent left femoropopliteal bypass (fp bypass) surgery for treatment of left superficial femoral artery (sfa) total occlusion.One year later, since the fp bypass graft was becoming totally occluded, recanalization was attempted using endovascular therapy (evt).Bare-metal nitinol stent (bns) of two smart stents (cordis, miami, fl; 7.0 × 120 mm, 6.0 × 150 mm) and one misago stent (terumo, tokyo, japan; 7.0 × 60 mm) were deployed to cover the entire lesion (fig.1a).The patient was discharged with prescriptions for oral anticoagulant (warfarin) and antiplatelet agents (aspirin 100 mg, clopidogrel 75 mg).At 9 months after first evt, angiography showed total occlusion of the left sfa.Four zilver ptx stents; paclitaxel-coated stent (pcs) (cook medical, bloomington, indiana; 7.0 × 60 mm, 7.0 × 100 mm, 7.0 × 100 mm, 7.0 × 100 mm) were deployed to cover all lesions with bns and one express stent (7.0 × 27 mm) was interpolated for under expansion lesion of pcs (fig.1a).Six months after second evt, due to progressive limb ischemia, above-the-knee amputation of the left limb was performed and the specimen harvested.Microscopic observation revealed massive thrombus formation, mainly on the luminal side of the stent struts (fig.1b).Existing neointimal tissue exhibited remarkable shedding and disappearance from the luminal surface of the pcs and most of which consisted of amorphous necrotic tissue (fig.1b, c).Nuclear ghosts were scattered among amorphous material consisting of necrotic tissue and fibrin components (fig.1d).

• 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: 9903867
• MDR Text Key: 240119872
• Report Number: 3001845648-2020-00175
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• 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
• Report Date: 02/23/2021

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?: 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
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/16/2020
• Initial Date FDA Received: 03/31/2020
• Supplement Dates Manufacturer Received: 03/16/2020; 03/16/2020; 03/16/2020
• Supplement Dates FDA Received: 05/21/2020; 01/08/2021; 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention