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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:
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Catalog Number UNKNOWN
Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)
Patient Problems Hyperplasia (1906); Stenosis (2263); Claudication (2550)
Event Date 05/09/2019
Event Type  Injury  
Manufacturer Narrative
Common name = stent, superficial femoral artery, drug-eluting; product code = niu.Rpn / lot numbers were confirmed as: zisv6-35-125-6.0-80-ptx-c-ci / lot cf1313206.Zisv6-35-125-6.0-80-ptx-c-ci / lot cf1313206.Zisv6-35-125-6.0-60-ptx-c-ci / lot cf1310775.(b)(6).Pma/510(k) number = p100022.(b)(4).This report includes information known at this time.A follow-up report will be submitted at the conclusion of the investigation or, when additional relevant information becomes available.
 
Event Description
It was previously reported in medwatch 1820334-2019-00049, after undergoing an endovascular index procedure using three zilver paclitaxel-eluting peripheral stents, a patient developed in-stent restenosis 209 days after the procedure which required a second procedure, bare balloon angioplasty, which was successful with a residual stenosis of <50%.The stents were placed as part of a clinical study.Three hundred sixty-one days post endovascular index procedure, a clinical follow-up was performed and a restenosis was identified in the study lesion.The patient was taking aspirin and clopidogrel.The study leg ankle brachial index (abi) was 0.73 with a rutherford classification of one.An ultrasound revealed patency proximal and distal to the study lesion.There was a 50-99% stenosis within the study lesion.Four hundred six days post endovascular index procedure, a secondary intervention was performed within the study lesion.The rutherford classification of the study leg had advanced to three.The clinical signs and symptoms included worsening claudication and worsening rutherford classification.Treatment included percutaneous transluminal angioplasty with a drug-eluting balloon.This intervention was successful with residual stenosis <50%.The physician indicated this event was "possible" related to both the study device and the study procedure due to neointimal hyperplasia.The pre-existing condition of atherosclerosis either caused or contributed to this event.It was reported, the device did not malfunction or deteriorate in characteristics or performance.The patient was discharged the following day.It has been reported, no additional information is available relating to this event.The complaint stents remained implanted in the patient's anatomy; therefore, they are not available for investigation by the manufacturer.
 
Manufacturer Narrative
This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
 
Event Description
As part of the investigation, an image review was performed on 28may2019 and revised on 19jun2019.Per the image review, the distal stent was narrowed by three stenosis sequentially worsening from 60% in the superior stent to 70% at the central stent, to 80% in the inferior stent likely representing the stenosis found on ultrasound.The 70% stenosis at the central stent was at the location of a type iii fracture.The type iii fracture had progressed from the type ii fracture reported previously under mdr 1820334-2019-00049.A previously reported stretching (mdr 1820334-2019-00049) was reclassified to a type ii fracture.A recurrent stenosis in the distal stent coincided with the originally constrained segment and type iii fracture.The slightly more inferior type ii fracture was not associated with significant in-stent stenosis.
 
Manufacturer Narrative
Investigation - evaluation: reviews of the complaint history, documentation, instructions for use (ifu), imaging, and quality control procedures were 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 number of the device is unavailable; accordingly, a review of the device history record could not be conducted.The device is shipped with instruction for use (ifu).This document notes restenosis of the stented artery is listed as a known potential adverse event.Additionally, a review of the quality control procedures was conducted, and no gaps were discovered.From the information provided it is known that the patient had a medical history of coronary artery disease (cad), type ii diabetes, hyperlipidemia/hypercholesterolemia, hypertension, peripheral arterial disease (pad), atherosclerosis and had a cardiac pacemaker.Based on the information provided and no product returned, investigation has concluded that this event cannot be traced to the device but to the patient¿s condition.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.
 
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MDR Report Key8641468
MDR Text Key146220121
Report Number1820334-2019-01279
Device Sequence Number1
Product Code NIU
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 07/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received07/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age81 YR
Patient Weight70
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