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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 1550400-08
Device Problems Improper or Incorrect Procedure or Method; Migration
Event Date 01/03/2020
Event Type  Injury  
Manufacturer Narrative

Exemption number e2019001. (b)(4). The device was not returned for analysis. A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided. It was reported the xience sierra stent delivery system (sds) was inflated above the rated burst pressure of 16 atms. It should be noted that the xience sierra everolimus eluting coronary stent system instruction for use states: do not exceed rated burst pressure (rbp) as indicated on product label. Monitor balloon pressure during inflation. The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the balloon catheter used to perform post-dilation interacted with the deployed stent causing the reported stent migration with the treatments of additional therapy/non-surgical treatment, additional therapy/delayed treatment, and removal of a foreign body. 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 performed to treat a non-tortuous, non-calcified left main lesion. The 4. 0x08mm xience sierra stent was deployed at 20 atmospheres. Post-dilatation was done with a 5. 5x20mm non-abbott balloon and when the balloon was retrieved, the stent came back with it and became loose in the anatomy. The stent was retrieved with a snare device. There was a 1 hour 10 minutes delay in the procedure. A new non-abbott stent was used to treat the lesion. There was no adverse patient sequela reported. 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
cashel road
clonmel tipperary
EI 
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula , CA 92591-4628
9519143996
MDR Report Key9603727
Report Number2024168-2020-00769
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/17/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/17/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number1550400-08
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 Received01/03/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 01/17/2020 Patient Sequence Number: 1
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