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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE ALPINE DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Model Number 1125300-18
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Intimal Dissection (1333); Angina (1710); Dyspnea (1816); Fatigue (1849); Stenosis (2263)
Event Date 08/08/2018
Event Type  Injury  
Manufacturer Narrative
Exemption number e2019001. The stent remains in patient. The device will not be returned for evaluation. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
Patient id: (b)(6). It was reported that on (b)(6) 2018, a 3. 0x18mm (1125300-18, 8021261) xience alpine stent was implanted in the mid left anterior descending (lad) coronary artery lesion. Stent malposition and a proximal edge dissection was observed. Additional post-dilatation was performed as treatment. Reportedly, following the additional post-dilatation (using the maximum balloon size and maximum pressure), there remained sub-optimal, distal stent expansion. No additional treatment was provided. On (b)(6) 2019, the patient was hospitalized for increasing dyspnea, chest tightness/pain, and fatigue. Another cardiac catheterization was performed and lad in-stent restenosis was observed along with severe three vessel disease. On (b)(6) 2019, a coronary artery bypass surgery was performed as treatment. No additional information was provided regarding this issue.
 
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Brand NameXIENCE ALPINE
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 # 2024168
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key9560331
MDR Text Key177787266
Report Number2024168-2020-00443
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/25/2021
Device Model Number1125300-18
Device Catalogue Number1125300-18
Device Lot Number8021261
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 Received01/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/26/2018
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: 01/07/2020 Patient Sequence Number: 1
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