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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 1809300-48
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Prolapse (2475)
Event Date 09/09/2020
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. It should be noted that the reported patient effect of prolapse is listed in the xience skypoint, everolimus eluting coronary stent system 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. The xience abt ng des 48 stent is currently not commercially available in the us; however, it is similar to a device sold in the us.
 
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 and a 3. 0x48mm xience stent was successfully implanted. Following, a plaque shift/disruption occurred, treated with a 3. 5x15mm xience sierra stent. 0% residual stenosis was observed and the event resolved without sequela. Reportedly, there was no device malfunction. No additional information was provide 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 Key10621868
MDR Text Key209654888
Report Number2024168-2020-08232
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 10/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/06/2021
Device Catalogue Number1809300-48
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 Received09/13/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/02/2020 Patient Sequence Number: 1
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