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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

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ABBOTT VASCULAR XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1070300-48
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Thrombosis (2100); Prolapse (2475)
Event Date 11/17/2020
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(s) of thrombosis is listed in the xience xpedition 48 everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary procedures. A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined. However, the 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.
 
Event Description
Patient id: (b)(6). It was reported that on (b)(6) 2020, the patient presented with a proximal left anterior descending (lad) 75% stenosed lesion and a percutaneous coronary intervention (pci) was performed. A 3. 0x48mm xience xpedition stent (1070300-48, 9082841) was implanted in the proximal lad with acceptable results. Reportedly, post-implantation, there was intra-stent plaque protrusion and thrombus. As treatment, additional dilatation was performed. 0% residual stenosis and timi grade iii was observed post-procedure. On (b)(6) 2020, the patient started experiencing chest pain. On (b)(6) 2020, a cardiac magnetic resonance imaging (mri) was performed. 5-10% ischemia was observed in the lad territory. On (b)(6) 2021, another diagnostic pci was performed. Reportedly, the xience xpedition stent had remained patent, without any disease progression, and there was no device malfunction. No treatment was required. Per physician, the event was unrelated to the xience xpedition stent. No additional information was provided regarding this issue.
 
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Brand NameXIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM
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 Key11305017
MDR Text Key233044357
Report Number2024168-2021-01036
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeSZ
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
Type of Report Initial
Report Date 02/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/04/2022
Device Catalogue Number1070300-48
Device Lot Number9082841
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 Received01/18/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/09/2021 Patient Sequence Number: 1
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