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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE XPEDITION DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1078300-48
Device Problems Inflation Problem; Improper or Incorrect Procedure or Method
Event Date 12/20/2019
Event Type  Malfunction  
Manufacturer Narrative

Exemption number e2019001. (b)(4). The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information. The xience xpedition 48 is currently not commercially available in the us; however, it is similar to a device sold in the us.

 
Event Description

It was reported that the procedure was to treat a lesion located in the distal right coronary artery that was mildly calcified, mildly tortuous and 90% stenosed. During attempted deployment of the 3. 0 x48 mm xience xpedition 48 stent, the balloon failed to inflate to deploy the stent. Trouble shooting was attempted, including changing the contrast to saline percentage, but unsuccessful, so the device was attempted to be removed. During removal, the balloon was thought to be inflated to 6 atmospheres, but because the thought was that it could not be inflated, it was unintentionally deployed in the middle part of the lesion. Two additional non-abbott stents were deployed, one distal and one proximal to the xience xpedition stent. There was no reported adverse patient effect or a clinically significant delay in the procedure. No additional information was provided.

 
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Brand NameXIENCE XPEDITION
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 Key9583114
Report Number2024168-2020-00625
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 01/13/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/13/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number1078300-48
Device LOT Number8050841
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/22/2018
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: 01/13/2020 Patient Sequence Number: 1
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