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

Model Number	G24888
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510(k) #: p100022.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 or Problem Description
(b)(6), study pt, occlusion/restenosis within & proximal to study lesion possibly related to study product.One zilver® ptx® v study stent was placed during the index procedure on (b)(6) 2015.The study lesion was the left distal sfa, 20 mm in length, with 75% diameter stenosis.There were two patent runoff vessels.The patient underwent pre-dilatation of study lesion with one inflation of a 5.0 x 40 mm balloon at 12 atm for 60 seconds.One zilver® ptx® v study stent was placed in the left distal superficial femoral artery via contralateral access.Post-stent dilatation was performed with three inflations of a 5.0 mm x 20 mm dilatation balloon at 20 atm for 20 seconds, 30 seconds, and 30 seconds.At the end of the case, there was 20% residual stenosis remaining in the study lesion, no thrombus was present.On the same day, the patient was discharged from the hospital taking aspirin and plavix.On (b)(6) 2016 (281 days post-procedure), the patient experienced an occlusion/restenosis of the study lesion requiring intervention as previously reported.On (b)(6) 2017 (604 days post-procedure), the patient experienced an occlusion/restenosis of the study lesion requiring intervention as previously reported.On (b)(6) 2018 (1185 days post-procedure), the patient complained of left lower extremity claudication, worsened claudication/rest pain.On (b)(6) 2018 (1197 days post-procedure), the patient underwent a secondary intervention as previously reported.On (b)(6) 2019 (1438 days post-procedure), the patient was diagnosed with an occlusion/restenosis within and proximal to the study lesion.The physician indicated was ¿possibly¿ related to the study product.The pre-existing condition of peripheral arterial disease (pad) caused or contributed to the event.The patient continued taking aspirin and plavix the secondary intervention was performed on (b)(6) 2019 (1478 days post-procedure).The pre-intervention diameter stenosis was occluded.The treatment provided was percutaneous, including atherectomy, use of a cutting balloon.The secondary intervention was deemed successful with residual stenosis <50%.
Additional Manufacturer Narrative
Pma/510(k) #: p100022.This report is being submitted as a cancellation report based on additional information received.Additional information indicates that a supera stent was placed over the zilver stent prior to this event.This "effectively removed the zilver stent from circulation" therefore this event is not related to the device.
Event or Problem Description
This report is being submitted as a cancellation report based on additional information received.Additional information indicates that a supera stent was placed over the zilver stent prior to this event.This "effectively removed the zilver stent from circulation" therefore this event is not related to the device.12-004, study pt, occlusion/restenosis within & proximal to study lesion possibly related to study product.One zilver® ptx® v study stent was placed during the index procedure on (b)(6) 2015.The study lesion was the left distal sfa, 20 mm in length, with 75% diameter stenosis.There were two patent runoff vessels.The patient underwent pre-dilatation of study lesion with one inflation of a 5.0 x 40 mm balloon at 12 atm for 60 seconds.One zilver® ptx® v study stent was placed in the left distal superficial femoral artery via contralateral access.Post-stent dilatation was performed with three inflations of a 5.0 mm x 20 mm dilatation balloon at 20 atm for 20 seconds, 30 seconds, and 30 seconds.At the end of the case, there was 20% residual stenosis remaining in the study lesion, no thrombus was present.On the same day, the patient was discharged from the hospital taking aspirin and plavix.On (b)(6) 2016 (281 days post-procedure), the patient experienced an occlusion/restenosis of the study lesion requiring intervention as previously reported.On (b)(6) 2017 (604 days post-procedure), the patient experienced an occlusion/restenosis of the study lesion requiring intervention as previously reported.On (b)(6) 2018 (1185 days post-procedure), the patient complained of left lower extremity claudication, worsened claudication/rest pain.On (b)(6) 2018 (1197 days post-procedure), the patient underwent a secondary intervention as previously reported.On (b)(6) 2019 (1438 days post-procedure), the patient was diagnosed with an occlusion/restenosis within and proximal to the study lesion.The physician indicated was ¿possibly¿ related to the study product.The pre-existing condition of peripheral arterial disease (pad) caused or contributed to the event.The patient continued taking aspirin and plavix.The secondary intervention was performed on (b)(6) 2019 (1478 days post-procedure).The pre-intervention diameter stenosis was occluded.The treatment provided was percutaneous, including atherectomy, use of a cutting balloon.The secondary intervention was deemed successful with residual stenosis <50%.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Common Device Name: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8888381
• Report Number: 3001845648-2019-00408
• Device Sequence Number: 335916
• Product Code: NIU
• UDI-Device Identifier: 10827002248882
• UDI-Public: (01)10827002248882(17)151202(10)C1066803
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/02/2015
• Device Model Number: G24888
• Device Catalogue Number: ZIV6-35-125-6-40-PTX
• Device Lot Number: C1066803
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/11/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR