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

Catalog Number UNKNOWN

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

Patient Problems Stenosis (2263); Restenosis (4576)

Event Date 09/06/2019

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: p100022/s027.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Saratzis et al 2019 (zilver ptx) ¿ ¿interwoven nitinol stents versus drug eluting stents in the femoro-popliteal segment: a propensity matched analysis¿.Procedure: a subintimal approach was necessary in 171 (58%) patients.Following plain balloon angioplasty, 136 patients (46%) received a sps and 160 (64%) patients a des (121 a zilver ptx and 39 an eluvia stent).Most patients required implantation of more than one stent: a single stent was used in 175 patients (49%), while 80 (27%) received two stents, 60 (20%) three stents, and 11 (4%) four stents.The decision of whether to use a sps or des was taken intra-operatively, and was operator dependent.83 patients developed a restenosis >50% within the treated f-p segment (primary outcome of interest).Among those 83 patients, 19% of des patients underwent re-intervention, including re-intervention for occlusion.This complaint will capture 30 cases of restenosis requiring reintervention.(19% of 160 des patients=30).This file will capture the potential that this event occurred in the (b)(6) and pr319080 will capture the potential that this event occurred in (b)(6).Patient outcome: all patients with a restenosis >50% were discussed in a multidisciplinary meeting.Those who were offered reintervention had deterioration in clinical symptoms (12 individuals) or a decrease in ankle brachial index of =20% (11 individuals).Patient/event ifo - notes: a total of 296 patients (mean age: 73 years, sd: 11 years, 65% male) met the inclusion criteria; 32% presented with severe claudication (class 3), 22% with rest pain (class 4), 43% with minor tissue loss (class 5), and 2% with severe tissue loss (class 6), as per rutherford classification.A total of 1801 lower limb angioplasties were performed in the department during this period.No patients were excluded because of non-availability of computed tomographic angiogram (cta) at baseline.

Manufacturer Narrative

Pma/510(k) #: p100022/s027.Device evaluation: the unknown devices of unknown lot number involved in this complaint were implanted in the patients and were 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 restenosis of the stented artery is listed as a known potential adverse event within the instructions for use (ifu0117-5).There is no evidence to suggest the user did not follow the ifu.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/underlying conditions.From the literature article it is known that patient pre-existing conditions included hypertension, hypercholesterolaemia, diabetes, smoking, renal insufficiency, history of ischaemic heart disease and rutherford classifications between 2 and 6.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.Summary: complaint is confirmed based on customer testimony.All patients with a restenosis >50% were discussed in a multidisciplinary meeting.Those who were offered reintervention had deterioration in clinical symptoms (12 individuals) or a decrease in ankle brachial index of =20% (11 individuals).

Event Description

Supplemental report is being submitted due to the completion of the investigation.

• 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
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 11278969
• MDR Text Key: 233472236
• Report Number: 3001845648-2021-00052
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/06/2019
• Event Location: Hospital
• Date Manufacturer Received: 01/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 73 YR
• Patient Sex: Male