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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 1070250-48
Device Problems Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance
Event Date 11/19/2019
Event Type  Malfunction  
Manufacturer Narrative

Exemption number e2019001. (b)(4). The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other incidents from this lot. It should be noted that the xience xpedition everolimus eluting coronary stent system instruction for use states: note: do not exceed rbp as indicated on product label. Balloon pressures should be monitored during inflation. Use of pressures higher than specified on product label may result in a ruptured balloon with possible intimal damage and dissection. The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the 80% stenosed, moderately tortuous and heavily calcified causing the reported difficulty to advance. After the device was advanced to the lesion the balloon was inflated above the labeled rated burst pressure (against instructions for use) causing the reported material rupture. There is no indication of a product quality issue with respect to manufacture, design or labeling.

 
Event Description

It was reported that the procedure was performed to treat an 80% stenosed, moderately tortuous, and heavily calcified de novo lesion in the right coronary artery. Resistance with the anatomy was felt when advancing a 2. 5x48mm xience xpedition stent delivery system (sds). The balloon ruptured at 20 atmospheres. The sds was removed with the stent still on the balloon. The procedure was successfully completed with the deployment of a 2. 75x48mm xience xpedition stent. There were no adverse patient effects and no 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 Key9462308
Report Number2024168-2019-14482
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 12/12/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/12/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number1070250-48
Device LOT Number9062741
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 Received11/22/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/03/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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