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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
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ABBOTT VASCULAR XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1120300-38
Device Problems Product Quality Problem (1506); Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/13/2021
Event Type  malfunction  
Event Description
It was reported that during preparation of the 3.0x38mm xience alpine stent delivery system (sds), the protective sheath was very tight and could not be removed with the usual ease and the balloon was noted to be inflated.There was no device use or patient involvement.Another non-abbott device was used to complete the procedure.There was no clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that during preparation of the 3.0x38mm xience alpine stent delivery system (sds), the protective sheath was very tight and could not be removed with the usual ease and the balloon was noted to be inflated.There was no device use or patient involvement.Another non-abbott device was used to complete the procedure.There was no clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was received: the sds was not prepared and it was during removal of the protective sheath when the physician realized the balloon was already inflated.No additional information was provided.
 
Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.Analysis confirmed the reported product quality problem (partial inflation).The reported difficult to remove (sheath) could not be tested due to the component not being returned.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.Additionally, factors that could contribute to a product quality problem (partial inflation) during preparation include, but are not limited to, inadvertent pressurization during preparation, mishandling of the device, and/or a manufacturing nonconformity.Factors that could contribute to difficult to remove (sheath) include, but are not limited to, user technique, damage to the balloon, and/or damage to the stent.Due to the degree of the flared stent, it is unlikely that the protective sheath would have fit over the damaged stent; therefore, the stent damage is not a pre-existing condition.In this case, it is possible that the user¿s technique during removal of the protective sheath contributed to the reported difficult to remove (sheath).It is also possible that the sds was inadvertently partially inflated during preparation for use, resulting in the reported product quality problem (partial inflation), ultimately causing the noted material deformation (flared proximal/distal stent struts); however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
 
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Brand Name
XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Type of Device
DRUG 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 Key13137622
MDR Text Key284192262
Report Number2024168-2022-00001
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeMX
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/14/2024
Device Catalogue Number1120300-38
Device Lot Number1030841
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/24/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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