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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

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ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012272-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intimal Dissection (1333)
Event Date 01/05/2021
Event Type  Injury  
Manufacturer Narrative
The device was not returned for evaluation. The reported patient effect of dissection is listed in the coronary dilatation catheters (cdc), trek rx, instruction for use as a known patient effect. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. A conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined. The additional treatment appears to be related to circumstances of the procedure. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
Event Description
It was reported that the procedure was performed to treat a moderately tortuous and heavily calcified lesion in the proximal circumflex artery. The lesion was pre-dilated with a 2. 5x20mm trek rx balloon dilatation catheter (bdc). A 2. 5x23mm xience sierra stent delivery system (sds) was advanced; however, failed to cross due to resistance with the anatomy. A 2. 25x15mm xience sierra was advanced and deployed. A small dissection was noted, and ballooning was performed. Post procedure, angio was reviewed and it was noted that the dissection occurred after pre-dilatation with the 2. 5x20mm trek rx bdc. The 2. 5x23mm xience sierra sds never reached the lesion site or dissection. Angio review confirmed that the dissection was successfully treated with the deployment of the 2. 25x15mm xience sierra and ballooning. There were no adverse patient sequela and no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameTREK CORONARY DILATATION CATHETER
Type of DeviceCORONARY DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR COSTA RICA, REG # 3009564766
52 calle 3 b31 coyol free zone
el coyol alajuela
CS
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key11141366
MDR Text Key225833434
Report Number2024168-2021-00268
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 01/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1012272-20
Device Catalogue Number1012272-20
Device Lot Number00731G1
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 Received01/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2020
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: 01/08/2021 Patient Sequence Number: 1
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