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

Catalog Number ZISV6-35-125-6.0-100-PTX

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

Patient Problem Occlusion (1984)

Event Date 05/18/2017

Event Type  Injury  

Manufacturer Narrative

Pms/ 510 k #: p100022/s014.Device evaluation: this complaint is related to pr 165762, please refer to this files for details of the investigation.The zisv6-35-125-6.0-100-ptx device of lot number c1264109 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 zisv6-35-125-6.0-100-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 zisv6-35-125-6.0-100-ptx of lot number c1264109 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 c1264109.Restenosis of the stented artery is listed as a known potential adverse event within the instructions for use (ifu0117-3).There is no evidence to suggest that the user did not follow the instructions for use.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient pre-existing conditions.Restenosis of the stented artery is also listed as a known potential adverse event within the ifu and is a common adverse event of endovascular procedures that can be caused by injury to the vessel (e.G.During percutaneous transluminal angioplasty (pta) and/or stenting).Vessel injury provokes an inflammatory response that leads to or amplifies the restenosis process.It may be noted that the surface of the zilver ptx stent is coated with the drug paclitaxel to help prevent subsequent restenosis of the artery.From the information provided it is known that the patient had a medical history of coronary artery disease, congestive heart failure and type ii diabetes.It is possible that theses pre-existing conditions may have contributed to this event.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the patient required additional stenting as a result of this event.The patient remained in the study but later passed away as a result of cardiac decompensation.From the information provided it is known that the study stent did not contribute to the passing of the patient.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

12-011, study pt with occlusion/restenosis within study lesion ¿possibly¿ r/t study device.On (b)(6) 2016 during the index procedure the patient received one zilver© ptx© stent.The study lesion was in the left distal sfa, 80 mm in length.The lesion status was de novo lesion with moderate calcification, no thrombus, a patent inflow tract, and three patent runoff vessels.The proximal reference vessel diameter (rvd) was 5.5 mm, the distal rvd was 5.0 mm with 80% diameter stenosis in study lesion.The lesion was pre-dilated with a bare balloon angioplasty.One study stent was deployed into the study lesion.There were no difficulties during the procedure and no residual stenosis remaining.The patient was discharged on (b)(6) 2016.On (b)(6) 2016, the patient was diagnosed with an occlusion/restenosis within the study lesion as previously reported (pr#165762.) on (b)(6) 2017 (206 days post-procedure), the patient was diagnosed with an occlusion/restenosis within the study lesion (the left greater saphenous vein left femoro-popliteal bypass).The clinical sign and symptom were rest pain.Treatment included stenting.The site indicated that ¿there were arterial stenosis before the study¿, a pre-existing condition caused or contributed to the event.The event was ¿possibly¿ related to the study device.The device did not malfunction or deteriorate in characteristics or performance.On (b)(6) 2018 (466 days post-procedure), the patient was diagnosed with cardiac decompensation.On (b)(6) 2018 (478 days post-procedure), the patient died due to the cardiac decompensation which the site has indicated was not related to the study product or procedure.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 as the patient was diagnosed with an occlusion/restenosis within the study lesion (the left greater saphenous vein left femoro-popliteal bypass) and required intervention "treatment included stenting".

• 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
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: heather ryan ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 9176911
• MDR Text Key: 168576422
• Report Number: 3001845648-2019-00516
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002352848
• UDI-Public: (01)10827002352848(17)180615(10)C1264109
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2018
• Device Catalogue Number: ZISV6-35-125-6.0-100-PTX
• Device Lot Number: C1264109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/18/2017
• Event Location: Hospital
• Date Manufacturer Received: 09/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2016
• 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: 77 YR
• Patient Weight: 65