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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC
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COOK INC Back to Search Results
Catalog Number UNKNOWN
Device Problem Occlusion Within Device (1423)
Patient Problem Edema (1820)
Event Date 01/12/2018
Event Type  Injury  
Manufacturer Narrative
Common name = stent, superficial femoral artery, drug-eluting; product code = niu.Per the initial reporter, the device will not be returned.(b)(4).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 that during an endovascular index procedure, two zilver© ptx© stents were placed in the right, distal superficial femoral artery (sfa).The baseline lesion morphology showed a mild, calcified, de novo lesion with no thrombus present.The inflow tract was 51-99% stenosed and was treated during procedure.There were three patent run-off vessels present.The study lesion was 100 millimeters (mm) in length and the percentage diameter stenosis in study lesion was 100 %.The patient had both a pre-and-post dilatation performed.The post-stent dilatation was performed with one inflation for 30 seconds.One-day post-procedure.The study ankle-brachial index (abi) was measured to be 0.8.Thirty-two 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.On an unknown date (at least on day of procedure), the patient experienced reperfusion edema in the study leg.The treatment was compression stockings and lymphatic drainage.The endovascular procedure was noted as having a causal relationship to the treatment because it is often seen after percutaneous transluminal angioplasty (pta) due to the positive outcome of the procedure and was not considered device related.Peripheral arterial disease is also noted as being causal or contributive to the event.Two hundred-seven days post-procedure, the six month clinical assessment showed a study leg rutherford classification of 1 and no walking problems on the walking impairment questionnaire.The abi was 0.9.Also noted on an ultrasound, was a low-grade in-stent-stenosis in the study lesion.No treatment was performed.According to the complainant, it was not possible to ascertain which of the zilver© ptx© stents had stenosed.The patient had received heparin, clopidogrel and marcumar throughout the course of the study from the procedure date.According to the initial reporter, the patient remains in the study.
 
Manufacturer Narrative
Investigation ¿ evaluation a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and trends of the device 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.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the 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.Refer to section h10 for investigation findings.
 
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Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
MDR Report Key7545613
MDR Text Key109309686
Report Number1820334-2018-01366
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
Report Date 08/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received08/16/2018
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age70 YR
Patient Weight65
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