MAUDE Adverse Event Report: COOK INC ZILVER PACLITAXEL-ELUTING PERIPHERAL STENT

Catalog Number ZISV6-35-125-6.0-80-PTX-C-CI

Device Problem Obstruction of Flow (2423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2018

Event Type  malfunction  

Manufacturer Narrative

Common name = stent, superficial femoral artery, drug-eluting; product code = niu.Pma/510(k) number = p100022.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported a (b)(6)-year-old male underwent an endovascular procedure on (b)(6) 2017 as part of a clinical study utilizing zilver paclitaxel-eluting peripheral stents.Two zilver paclitaxel-eluting peripheral stents were placed in the left, distal superficial femoral artery (sfa).Baseline lesion morphology showed a mild, calcified, de novo lesion with no thrombus present.The inflow tract was patent.There were three patent run-off vessels present.The proximal reference vessel diameter was 5 mm.The distal reference vessel diameter was 6 mm.The lesion length was 70 mm and the pre-procedure percentage diameter stenosis in the study lesion was 100 %.The patient had both a pre and a post dilation performed.There was no information regarding percent stenosis after the post dilatation.One-day post-procedure, an ankle-brachial index (abi) was measured to be 1.0.Twenty-nine days post-procedure, the one-month clinical assessment showed a study leg rutherford classification of 0 and only slight walking problems on the walking impairment questionnaire.The abi was 1.0.One hundred seventy-five days post-procedure, the six-month clinical assessment showed a study leg rutherford classification of 0 and slight walking problems on the walking impairment questionnaire.The abi was 0.73.The angiography result showed the percent diameter stenosis in the study lesion was 20 %.The proximal reference vessel diameter was 5.7 mm.The distal reference vessel diameter was 5.8 mm.Four hundred thirteen days post-procedure, the twelve-month clinical assessment showed a study leg rutherford classification of 1 and some walking problems on the walking impairment questionnaire.The abi was 0.82.The ultrasound result showed a moderate 60% in-stent restenosis.No medical intervention was required.It was considered possibly related to the device with the comment: ¿neointimal hyperplasia after stent implantation¿.The pre-existing condition of peripheral artery disease (pad) was also considered to have contributed to the event.The patient had received clopidogrel throughout the course of the study from procedure date.The patient remains in the study.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation evaluation.A review of the complaint history, device history record, documentation, instructions for use (ifu), manufactures instructions, and quality control was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot for this device was provided by cook ireland.A review of the manufacturing records for zisv6-35-125-6.0-60-ptx-c-ci did not reveal any discrepancies that could have contributed to this complaint issue.There is no evidence to suggest that the customer did not follow the instructions for use.Furthermore, images were provided to support the investigation.These images were reviewed, and the following comments were made.In-stent stenosis from neointimal hyperplasia in the proximal stent is confirmed on the 12 month ultrasound.A definitive root cause of in-stent restenosis from neointimal hyperplasia in the proximal stent was identified from the imaging review.From the information provided it is known that the patient had peripheral arterial disease (pad) which may have contributed to the event.Based on the information provided and no product returned, investigation has concluded that this event was a known and inherent risk of the device used.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ZILVER PACLITAXEL-ELUTING PERIPHERAL STENT
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8133333
• MDR Text Key: 129902892
• Report Number: 1820334-2018-03532
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-6.0-80-PTX-C-CI
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2019
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 80