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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 Material Separation (1562)
Patient Problem Pain (1994)
Event Date 01/13/2022
Event Type  Injury  
Event Description
It was reported in (b)(6) 2020, a 3x48mm xience xpedition drug eluting stent (des) was implanted to treat a lesion in the mildly calcified, mildly tortuous right coronary artery (rca) on (b)(6) 2022, the patient presented with discomfort and imaging was performed, which revealed that the stent was separated into two pieces. A 3x12mm non-abbott stent was implanted to cover the separated stent, without issue. There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy. No additional information was provided.
 
Manufacturer Narrative
Date of implant: estimated. The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history identified no similar incidents from this lot. The reported patient effect of pain is listed in the xience xpedition everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effect of coronary stenting procedures. A cine was received and reviewed by an abbott vascular clinical specialist: the reviewer concluded that the provided images confirm the reported event, but no probable cause can be determined. The investigation was unable to determine a conclusive cause for the reported material separation; however, factors that could contribute to material separation include, but are not limited to, interaction with accessory devices, over expansion of the stent, deployment technique, and/or anatomical characteristics. Based on the information provided it is unknown what may have caused the reported material separation. Additionally, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined; however, the subsequent 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. The xience xpedition 48 is currently not commercially available in the us; however, it is similar to a device sold in the us.
 
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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 Key13457604
MDR Text Key288305464
Report Number2024168-2022-01200
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeMY
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/23/2022
Device Catalogue Number1070300-48
Device Lot Number9041741
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/24/2019
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: 02/04/2022 Patient Sequence Number: 1
Treatment
RESOLUTE ONYX 3.0X12
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