• 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
Catalog Number 1550300-28
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Angina (1710); Dyspnea (1816); Myocardial Infarction (1969); Nausea (1970); Thrombosis (2100)
Event Date 06/26/2019
Event Type  Injury  
Manufacturer Narrative
The stent remains in patient. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. (b)(4). The stent remains in patient.
 
Event Description
It was reported that on (b)(6) 2019, the patient underwent a right coronary artery (rca) intervention. A 3. 0 x 33 mm xience sierra stent was implanted in the distal rca and a 3. 0 x 28 mm xience sierra stent was implanted in the proximal rca. The stents were not overlapping. The 3. 0 x 28 mm xience sierra in the proximal lesion was treated with additional balloon angioplasty; however, the stent remained under expanded. On (b)(6) 2019, the patient presented to the emergency room with severe retrosternal chest pain, shortness of breath and nausea. An electrocardiogram (ekg) was performed and noted st elevation, consistent with acute myocardial infarction due to acute thrombotic occlusion of the proximal under expanded xience sierra stent. Medications were administered and a revascularization procedure was performed, with angioplasty of the proximal rca stent. The under expansion of the proximal stent was felt to be due to heavy calcification in the vessel. The patient was re-hospitalized on (b)(6) 2019 for shockwave lithotripsy, in an effort to disrupt the calcium to allow full extension of the stent. Despite the intervention, the stent under expansion was better, but was still consistent with under expansion. Post procedure, the patient remained stable. No additional information was provided.
 
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 Key8834049
MDR Text Key152456939
Report Number2024168-2019-10413
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08717648227288
UDI-Public08717648227288
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 09/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Catalogue Number1550300-28
Device Lot Number8102341
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 Received09/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2018
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: 07/26/2019 Patient Sequence Number: 1
-
-