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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Occlusion (1984)

Event Date 05/21/2019

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: p100022/s001.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

(b)(6) - study pt, occlusion/restenosis within study stents, possibly related to study product and procedure.Two zilver® ptx® v study stents were deployed during the index procedure on (b)(6) 2015.The study lesion was the right distal sfa and popliteal artery.The study lesion was 120 mm long with 90% diameter stenosis, mild calcification and no thrombus.The proximal reference vessel diameter (rvd) was 4.92 mm and the distal rvd was 4.65 mm.There were three patent runoff vessels.Entry site was contralateral.Pre-stent dilatation was performed with one inflation of a 5 mm x 40 mm balloon.Post-stent dilatation was performed with one inflation of a 6 mm x 100 mm balloon.Post-stent dilatation was performed with two inflations 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) 2015 (five days post-procedure), taking aspirin and plavix.On (b)(6) 2017 (561 days post-procedure), the patient experienced an occlusion/restenosis of the study lesion requiring intervention.The patient continued to take aspirin and plavix.The secondary intervention was performed, and treatment included a balloon angioplasty.The physician determined that the occlusion/restenosis of the study lesion was probably related to the study product, possibly related to the study procedure, and the patient¿s pre-existing peripheral vascular disease caused or contributed to this event.On the same day, the patient was diagnosed with an ischemic ulcer on the right forefoot.Treatment included surgical debridement.The physician determined that the ischemic ulcer was probably related to the study product, probably related to the study procedure, and the patient¿s pre-existing peripheral vascular disease caused or contributed to this event.On (b)(6) 2018, the patient experienced an occlusion/restenosis of the study lesion that requiring intervention.The secondary intervention was performed, and treatment included a balloon angioplasty.The physician determined that the occlusion/restenosis of the study lesion was probably related to the study product, was unlikely to be related to the study procedure.The patient¿s pre-existing peripheral vascular disease and prior secondary intervention on (b)(6) 2017 caused or contributed to this event.The study stent did not malfunction or deteriorate in characteristics or performance.The site noted: ¿right leg angiography indications: arterial insufficiency; atherosclerosis with no significant inflow disease; severe in-stent stenosis of the sfa and above knee popliteal; patent all below knee vessels including plantar and dorsalis pedis.¿ this pr.On (b)(6) 2019 (1356 days post-procedure), the patient was diagnosed with an occlusion/restenosis within the study lesion requiring intervention.Treatment included balloon angioplasty.The physician indicated the event was possibly related to both the study product and procedure.The pre-existing condition of systemic atherosclerosis caused or contributed to the event.The site has not completed the secondary intervention form, no further information is available.

Manufacturer Narrative

Pma/510(k) #: p100022/s001 device evaluation this file is related to five other investigations.For details of the other investigations please refer to pr 179381, pr 180562, pr 181347, pr 226869 and pr 270902.This file addressed the may 2019 restenosis event involving the ziv6-35-125-6-100-ptx stent within the patient.The ziv6-35-125-6-100-ptx device of lot number c1129832 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 c1129832 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 c1129832.It should be noted that restenosis of the stented artery is listed as a known potential adverse event within the instructions for use (ifu0093-5).There is no evidence to suggest that the customer did not follow the instructions for use.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.'pr 270902 ver 2_275193 ver 1 imaging review'): impression 1.Ln-stent stenosis from neointimal hyperplasia (nih) is confirmed.It was most severe in the ziv6-35-125-6-100-ptx.On 12-month follow-up, the greater than 70% stenosis in the inferior stent matched where the stent bent with knee flexion.Diffuse less severe stenosis from nih through the remainder of the ziv6-35-125-6-100-ptx and the more proximal ziv6-35-125-6-40-ptx is confirmed.2.Focal 60% stenosis from progressive atherosclerosis developed superior the stents where the original stenosis was not stented or angioplastied.3.Although it is impossible to determine if all the stenoses developed in concert or if one was the primary lesion, development of the most severe stenosis at the same location where the ziv6-35-125-6-100-ptx bent with knee flexion suggests that knee flexion aggravated nih formation.Root cause review a definitive root cause could not be determined.A possible root cause could be attributed to aggravated neointimal hyperplasia (nih) formation at the location of the stents as a result of knee flexion.It is also possible that atherosclerosis contributed to the event.Restenosis is also listed as a known potential adverse event within the ifu.Summary complaint is confirmed as the failure was verified in the image(s).According to the initial reporter, the patient required balloon angioplasty as a result of this event.The patient remains in the study.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

12-004 - study pt, occlusion/restenosis within study stents, possibly related to study product and procedure two zilver® ptx® v study stents were deployed during the index procedure on (b)(6) 2015.The study lesion was the right distal sfa and popliteal artery.The study lesion was 120 mm long with 90% diameter stenosis, mild calcification and no thrombus.The proximal reference vessel diameter (rvd) was 4.92 mm and the distal rvd was 4.65 mm.There were three patent runoff vessels.Entry site was contralateral.Pre-stent dilatation was performed with one inflation of a 5 mm x 40 mm balloon.Post-stent dilatation was performed with one inflation of a 6 mm x 100 mm balloon.Post-stent dilatation was performed with two inflations 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 09/08/2015 (five days post-procedure), taking aspirin and plavix.On 17-mar-2017 (561 days post-procedure), the patient experienced an occlusion/restenosis of the study lesion requiring intervention.The patient continued to take aspirin and plavix.The secondary intervention was performed, and treatment included a balloon angioplasty.The physician determined that the occlusion/restenosis of the study lesion was probably related to the study product, possibly related to the study procedure, and the patient¿s pre-existing peripheral vascular disease caused or contributed to this event.On the same day, the patient was diagnosed with an ischemic ulcer on the right forefoot.Treatment included surgical debridement.The physician determined that the ischemic ulcer was probably related to the study product, probably related to the study procedure, and the patient¿s pre-existing peripheral vascular disease caused or contributed to this event.On 30-apr-2018, the patient experienced an occlusion/restenosis of the study lesion that requiring intervention.The secondary intervention was performed, and treatment included a balloon angioplasty.The physician determined that the occlusion/restenosis of the study lesion was probably related to the study product, was unlikely to be related to the study procedure.The patient¿s pre-existing peripheral vascular disease and prior secondary intervention on 03/22/2017 caused or contributed to this event.The study stent did not malfunction or deteriorate in characteristics or performance.The site noted: ¿right leg angiography indications: arterial insufficiency; atherosclerosis with no significant inflow disease; severe in-stent stenosis of the sfa and above knee popliteal; patent all below knee vessels including plantar and dorsalis pedis.¿ this pr on 05/21/2019 (1356 days post-procedure), the patient was diagnosed with an occlusion/restenosis within the study lesion requiring intervention.Treatment included balloon angioplasty.The physician indicated the event was possibly related to both the study product and procedure.The pre-existing condition of systemic atherosclerosis caused or contributed to the event.The site has not completed the secondary intervention form, no further information is available.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.Additional information received in the image review(15-aug-19) indicates that the ziv6-35-125-6-100-ptx was also occluded.The patient was diagnosed with an occlusion/restenosis within the study lesion requiring intervention.Treatment included balloon angioplasty.

• 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: 9009516
• MDR Text Key: 161812502
• Report Number: 3001845648-2019-00472
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002249353
• UDI-Public: (01)10827002249353(17)160519(10)C1129832
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2016
• Device Model Number: G24935
• Device Catalogue Number: ZIV6-35-125-6-100-PTX
• Device Lot Number: C1129832
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/21/2019
• Event Location: Hospital
• Date Manufacturer Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR