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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 1550300-15
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Dyspnea (1816); Myocardial Infarction (1969); Dyskinesia (2363)
Event Date 11/13/2019
Event Type  Injury  
Manufacturer Narrative
Exemption number e2019001. 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. The reported patient effect of myocardial infarction is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures. The investigation was unable to determine a conclusive cause for the reported patient-device incompatibility (wall apposition); however, factors that may contribute to patient-device incompatibility (wall apposition) include, but are not limited to, incorrect device size for lesion, patient anatomical morphology, and patient disease state, and insufficient post-dilation. The reported patient effects and treatment appear to be related to operational context of the procedure as it is likely the under deployed stent caused the reported myocardial infarction, dyspnea, dyskinesia, clamminess, additional therapy/non-surgical treatment and hospitalization. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
Study patient (b)(6). It was reported that the procedure was performed on (b)(6) 2019, treating a target lesion in the mid left anterior descending (lad) artery. The 3. 0 x 15 mm xience sierra stent was implanted without issue. On (b)(6) 2019, the patient was working at home and developed difficulty breathing and shivering, with clamminess. Emergency medical services was called and administered aspirin. The patient was transported to the emergency department and hospitalized. The patient was hemodynamically stable. Troponin levels were elevated and non-st elevation myocardial infarction was diagnosed. The patient was taken to the cath lab and coronary angiography noted that the stent was underdeployed. Balloon angioplasty was performed. Antiplatelet medications were administered. The patient was observed for two days. The event resolved on 11/16/2019 and the patient was discharged to home. There was no additional information 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 Key9454870
MDR Text Key173713399
Report Number2024168-2019-14416
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 health professional,study
Reporter Occupation
Type of Report Initial
Report Date 12/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/12/2019
Device Catalogue Number1550300-15
Device Lot Number8090541
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 Received11/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/13/2018
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: 12/11/2019 Patient Sequence Number: 1
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