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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 1550250-33
Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)
Patient Problems Angina (1710); Thrombosis (2100)
Event Date 04/02/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the lot number was not provided.It should be noted that the xience sierra, everolimus eluting coronary stent system, instructions for use, specifies the rated burst pressure (rbp) is 16 atmospheres and clearly states not to exceed the rbp.Use of pressures higher than specified on the product label may result in a ruptured balloon with possible intimal damage and dissection.The investigation was unable to determine a conclusive cause for the reported difficulty to deploy (wall apposition); however, the subsequent treatments appear to be related to the circumstances of the procedure.The reported patient effects of angina and thrombosis are listed in the xience sierra ifu as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
 
Event Description
It was reported that on (b)(6) 2019, the patient had the 2.50.33 mm xience sierra stent implanted at 20 atmospheres (atm) in the heavily calcified, moderately tortuous proximal left anterior descending coronary artery.The patient was still in the hospital due to other health issues on (b)(6) 2019 when it was noted there was an acute closure of the xience sierra stent in the lad.The patient was experiencing chest pain, so the films from (b)(6) 2019 were reviewed and it was noted the sierra stent was dogboned and severely under-deployed in multiple areas.Thrombus was noted throughout the entire stent.Thrombectomy was performed followed by multiple balloon inflations with a high pressure balloon to successfully appose the stent.The patient is stable and doing fine.No additional information was provided.
 
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Brand Name
XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Type of Device
DRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168
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 Key8515649
MDR Text Key141976888
Report Number2024168-2019-02935
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08717648227134
UDI-Public08717648227134
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 Physician
Remedial Action Other
Type of Report Initial
Report Date 04/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1550250-33
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/02/2019
Initial Date FDA Received04/15/2019
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 Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age72 YR
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