MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT

Model Number G24888

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Reocclusion (1985); Stenosis (2263)

Event Date 05/21/2019

Event Type  Injury  

Manufacturer Narrative

Common device name: niu stent, superficial femoral artery, drug-eluting.Product code: niu.

Event Description

Two zilver ptx v study stents were deployed during the index procedure on (b)(6) 2015.The study lesion was the right distal sfa (superficial femoral artery) 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, taking aspirin and plavix.On (b)(6) 2017, 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.¿ on (b)(6) 2019, 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.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8861119
• MDR Text Key: 153722037
• Report Number: 3005580113-2019-00104
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002248882
• UDI-Public: (01)10827002248882(17)160409(10)C1134169
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2016
• Device Model Number: G24888
• Device Catalogue Number: ZIV6-35-125-6-40-PTX
• Device Lot Number: C1134169
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/05/2019
• Distributor Facility Aware Date: 07/17/2019
• Device Age: 46 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2019
• Date Device Manufactured: 07/22/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR