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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ABBOTT NEXT GENERATION DES 48 DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

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ABBOTT VASCULAR ABBOTT NEXT GENERATION DES 48 DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1809350-48
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intimal Dissection (1333); Cardiac Enzyme Elevation (1838)
Event Date 09/30/2020
Event Type  Injury  
Manufacturer Narrative
The device was not returned for evaluation. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. The reported patient effect of dissection is listed in the xience skypoint, everolimus eluting coronary stent system (eecss), instructions for use, as a known patient effect of coronary stenting procedures. A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the reported treatment appears to be related to the operational context of the procedure. There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
 
Event Description
Patient id: (b)(6). It was reported that on (b)(6) 2020, a percutaneous coronary intervention was performed on the mid left anterior descending (lad) coronary artery lesion. Pre-dilatation was performed, a 3. 5x48mm abt ng des stent was successfully implanted and post-dilated. Following, a dissection was observed. As treatment, a 2. 75x18mm xience sierra stent was successfully implanted. There was no device malfunction. 0% residual stenosis was observed and the event resolved that same day. Post-procedure, elevated cardiac enzymes were observed. There was no treatment nor any prolonged hospitalization reported due to this elevation. No additional information was provided regarding this issue.
 
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Brand NameABBOTT NEXT GENERATION DES 48
Type of DeviceDRUG ELUTING CORONARY STENT DELIVERY SYSTEM
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005718570 (P099)
cashel road
clonmel tipperary
EI
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key10685495
MDR Text Key211544997
Report Number2024168-2020-08636
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Reporter Occupation
Type of Report Initial
Report Date 10/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/06/2021
Device Catalogue Number1809350-48
Device Lot Number00430P8
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 Received09/30/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/15/2020 Patient Sequence Number: 1
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