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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER

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AV-TEMECULA-CT RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number 1008193-20
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Stroke/CVA (1770); Coma (2417)
Event Date 05/16/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Concomitant products: stent: 8tx40x136 xact. Embolic protection device: emboshield nav6 lg 190cm. (b)(4). There was no reported device malfunction and the product was not returned. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. It should be noted that the viatrac instructions for use(ifu) states that the viatrac 14 plus peripheral dilatation catheter is intended: to dilate stenosis in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infrapopliteal, renal arteries). The reported patient effect of cerebrovascular accident, as listed in the viatrac instructions for use (ifu), is a known adverse event associated with the use of a peripheral device in native peripheral arteries. Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined. There is no indication of a product quality issue with respect to design, manufacture or labeling of the device. The emboshield nav6 device referenced is being filed under a separate manufacturing report number.
 
Event Description
It was reported that on (b)(6) 2017, the procedure was to treat a heavily calcified lesion in the moderately tortuous left internal carotid artery (lica). An emboshield nav6 lg 190cm embolic protection system (eps) was advanced past the lesion without issue. A 5x20x135 rx viatrac balloon was advanced and inflated without difficulty when, during inflation, the patient breathing became notably very labored then patient become totally unresponsive neurologically. No thrombus was noted, but a stroke was confirmed to have occurred. An 8tx40x136 xact stent was then successfully deployed, as planned, resulting in good flow and good overall result, as confirmed angiographically and on computerized tomography scan. The nav6 was retrieved without difficulty. No interventions were performed. While there were no device issues, the patient neurological deficit remains and patient remains comatose (but not intubated) and, as of (b)(6) 2017, is not expected to recover in the near future. No additional information was provided.
 
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Brand NameRX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
Type of DevicePERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key6603329
MDR Text Key76372425
Report Number2024168-2017-04655
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102705
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 05/31/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1008193-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/16/2017
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 Treatment Data
Date Received: 05/31/2017 Patient Sequence Number: 1
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