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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM

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AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Catalog Number 1550300-15
Device Problems Unintended System Motion (1430); Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923)
Patient Problem Intimal Dissection (1333)
Event Date 07/02/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information. The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all relevant information.
 
Event Description
It was reported that the procedure was performed to treat a lesion in the mid right coronary artery (rca). The 3. 0 x 15 mm xience sierra stent delivery system was advanced to the target lesion and the balloon was inflated to 10 atmospheres (atm). During deployment, it was noted that the balloon and stent moved backwards in the vessel, proximal to the target lesion. The stent moved on the delivery catheter balloon and was deployed in the rca, but not fully at the target lesion. Additional dilatation was required to fully appose the stent to the vessel wall. A distal edge dissection was noted and an additional stent was deployed to treat the dissection and the target lesion. Post procedure, the patient was in stable condition. There were no adverse patient sequelae and no clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Device not available for evaluation. The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other similar incidents from this lot. The reported patient effect(s) of dissection is listed in the xience sierra everolimus eluting coronary stent systems instructions for use (ifu) is a known patient effect of coronary stenting procedures. The investigation determined a conclusive cause for the reported difficulties cannot be determined. Additionally, a conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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Brand NameXIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Type of DeviceDRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
CLONMEL, IRELAND REG# 9616693
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key7715678
MDR Text Key114884197
Report Number2024168-2018-05712
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
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/22/2019
Device Catalogue Number1550300-15
Device Lot Number8041041
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 Received08/23/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2018
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: 07/24/2018 Patient Sequence Number: 1
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