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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 1070350-48
Device Problems Difficult to Remove (1528); Material Separation (1562)
Patient Problems Anemia (1706); Low Blood Pressure/ Hypotension (1914); Cardiogenic Shock (2262); Obstruction/Occlusion (2422); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Event Date 12/10/2021
Event Type  Injury  
Event Description
It was reported that the patient presented with an inferior wall myocardial infarction and the procedure was to treat a 30% stenosed with heavy thrombus and mildly calcified vessel in the right coronary artery (rca). The 3. 5x48mm xience xpedition stent delivery system (sds) reached the target lesion and was deployed with a pressure of 10 atmospheres (atms), however, there was moderate resistance as the balloon was stuck to the stent post-deployment during removal. While retrieving the sds, half of the balloon material was left in the artery. The separated portion is partially floating in the aorta and the rest of the balloon material is stuck in the stent implanted in the rca. The proximal part was withdrawn easily. The physician tried to retrieve the balloon with a snare device but was unsuccessful. Re-occlusion occurred. It was noted that the total procedure time extended to 6 hours. Patient is still admitted in the hospital with oxygen support. Prolonged hospitalization led to right ventricular failure & hypotension, cardiogenic shock, metabolic acidosis, thrombocytopenia with platelet count of 32,000, anemia (hemoglobin 7) and acute kidney injury with creatinine 2. 3. No additional information was provided.
 
Manufacturer Narrative
The stent remains in the patient. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
 
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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 Key13157339
MDR Text Key288134305
Report Number2024168-2022-00042
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeIN
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1070350-48
Device Lot Number1072041
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/26/2021
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: 01/04/2022 Patient Sequence Number: 1
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