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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE PROA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1128400-12
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 12/23/2020
Event Type  Injury  
Manufacturer Narrative
The device was not returned for evaluation. The reported patient effect of hypersensitivity is listed in the xience pro a/alpine everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary procedures. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the reported treatment appears to be related to the operational context of the procedure. There is no indication of a product quality issue with respect to manufacture, design or labeling of the device. The xience proa is currently not commercially available in the u. S; however, it is similar to a device sold in the u. S. The additional six xience alpine referenced are being filed under separate medwatch report numbers.
 
Event Description
It was reported that on (b)(6) 2018 a 2. 75x28mm, 3. 0x18mm, 2. 5x18mm, and a 3. 0x18mm xience alpine stents were deployed without issues. On (b)(6) 2020, a 3. 0x23mm and a 4. 0x38mm xience alpine stents and a 4. 0x12mm xience proa stent were deployed without issues. On (b)(6) 2020, the patient was re-admitted with unspecified health issues. Coronary bypass surgery was going to be performed; however, it was canceled because the patient was diagnosed with a suspicion of kounis syndrome due to an allergic reaction. Explanting the stents is being contemplated. There has been no treatment for the allergic reaction. No additional information was provided.
 
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Brand NameXIENCE PROA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
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 Key11158713
MDR Text Key226542602
Report Number2024168-2021-00377
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial
Report Date 01/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/29/2020
Device Catalogue Number1128400-12
Device Lot Number7112441
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/05/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/13/2021 Patient Sequence Number: 1
Treatment
STENT: 2.5X18MM XIENCE ALPINE; STENT: 2.75X28MM XIENCE ALPINE; STENT: 3.0X18MM XIENCE ALPINE; STENT: 3.0X18MM XIENCE ALPINE; STENT: 3.0X23MM XIENCE ALPINE; STENT: 4.0X38MM XIENCE ALPINE
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