• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT VASCULAR XIENCE SIERRA DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Model Number UNK RX XIENCE
Device Problems Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
Event Date 07/22/2019
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 remains implanted and 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

(b)(4). Patient id: (b)(6). It was reported that on (b)(6) 2019, a percutaneous coronary intervention (pci) was performed, placing an unspecified xience stent (s), without complications. On (b)(6) 2019, elevated troponin was observed and a new myocardial infarction (mi) was diagnosed. Reportedly, the patient had no symptoms. On (b)(6) 2019, another pci was performed as treatment in the 1st right posterior lateral and mid left anterior descending (lad) coronary artery lesions. The event resolved. No additional information was provided regarding this issue.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameXIENCE SIERRA
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 Key8898887
Report Number2024168-2019-10897
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,STUDY
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/09/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/15/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/20/2020
Device MODEL NumberUNK RX XIENCE
Device Catalogue Number1550400-33
Device LOT Number9021441
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 Received08/16/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/21/2019
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: 08/15/2019 Patient Sequence Number: 1
-
-