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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
Catalog Number 1145250-38
Device Problems Patient-Device Incompatibility (2682); Difficult to Advance (2920)
Patient Problem Perforation (2001)
Event Date 07/08/2019
Event Type  Injury  
Manufacturer Narrative
Exemption number (b)(4) permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition. There may be gaps in numbering for reports submitted during the transition period. The device will not be returned for evaluation, the device was reportedly discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The graftmaster device is being filed under a separate medwatch report #. Na.
 
Event Description
It was reported that the procedure was to treat a perforation in the mid right coronary artery. A 2. 5 x 20 mm trek balloon catheter was used for pre-dilatation. The first inflation was at 14 atmospheres (atm) and the second and third inflations were at 16 atm. A 2. 5 x 38 mm xience alpine stent was then implanted. However, a perforation was noted. There was then a failed attempt to advance a 2. 8 x 16 mm graftmaster covered stent as it could not pass through the xience alpine stent, which may not have been fully apposed to the vessel wall. Therefore, ballooning was performed several times with a 2. 5 x 15 mm nc trek balloon catheter which sealed the perforation. There was no adverse patient sequela reported. No additional information was provided.
 
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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 # 3005718570 (P099)
cashel road
clonmel tipperary CA
EI
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key8856282
MDR Text Key153133758
Report Number2024168-2019-10530
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/17/2021
Device Catalogue Number1145250-38
Device Lot Number8011041
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 Received10/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/18/2018
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: 08/02/2019 Patient Sequence Number: 1
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