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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE SIERRA DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1500250-18
Device Problems Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated
Event Date 11/21/2019
Event Type  Injury  
Manufacturer Narrative

Exemption number e2019001. (b)(4). 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 similar incidents from this lot. It should be noted that the xience sierra everolimus eluting coronary stent system instruction for use (ifu) states: an unexpanded stent may be retracted into the guiding catheter one time only. An unexpanded stent should not be reintroduced into the artery once it has been pulled back into the guiding catheter. Subsequent movement in and out through the distal end of the guiding catheter should not be performed, as the stent may be damaged or dislodged during retraction back into the guiding catheter. The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure as it is likely the device interacted with the difficult anatomy during advancement to the lesion causing the reported failure to advance. Additionally, the device was removed and then reinserted (against ifu) after further dilation of the lesion was performed. The device was advanced to the lesion and was unable to cross due to anatomy. During retraction the device interaction with the difficult anatomy and/or guiding catheter likely caused the reported stent dislodgement with the patient effects of removal of a foreign body. It should also be noted that the re-insertion of the device may have contributed to the reported stent dislodgement. There is no indication of a product quality issue with respect to manufacture, design or labeling.

 
Event Description

It was reported that the procedure was to treat an unspecified coronary artery. The 2. 5x18 mm xience sierra stent delivery system (sds) experienced resistance during advancement and was removed before it reached the lesion. Pre-dilatation was performed and the sds was advanced again; however, could not reach the lesion. Upon removal of the sds, the stent dislodged and remained in the patient. A balloon was used to retrieve the stent and a non-abbott sds was used to complete the procedure. There were no adverse patient sequela and there was no reported clinically significant delay in the procedure. No additional information was provided.

 
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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 Key9469223
Report Number2024168-2019-14530
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/13/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/13/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number1500250-18
Device LOT Number9060741
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 Received12/13/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/17/2019
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: 12/13/2019 Patient Sequence Number: 1
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