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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 1128400-23
Device Problems Deflation Problem (1149); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/05/2021
Event Type  malfunction  
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.The xience proa device is currently not commercially available in the us; however, it is similar to a device sold in the us.
 
Event Description
It was reported that the procedure was to treat a left circumflex to left main lesion.A 4x23 mm xience proa stent was used in the circumflex artery and deployed at around 12 atmospheres partially reaching the left main.There was resistance advancing due to calcification.The stent-balloon took a very long time to deflate but ultimately partially deflated.The partially deflated stent-balloon (still partially inflated) was enough to be accommodated by a 7 fr guide catheter and simply withdrawn.There was no adverse patient effect and no clinically significant delay.No additional information was provided.
 
Event Description
It was reported that the procedure was to treat a left circumflex to left main lesion.A 4x23mm xience proa stent was used in the circumflex artery and deployed at around 12 atmospheres partially reaching the left main.There was resistance advancing due to calcification.The stent-balloon took a very long time to deflate but ultimately partially deflated.The partially deflated stent-balloon (still partially inflated) was enough to be accommodated by a 7fr guide catheter and simply withdrawn.There was no adverse patient effect and no clinically significant delay.Subsequent to the initially filed mdr report, the account confirmed the xience proa stent was inflated once at 14 atmospheres rather than 12 atmospheres as previously reported.The stent-balloon was inflated for around 20-30 seconds before deflation was initiated.Additionally, it was confirmed that a very long time was held negative to deflate the balloon, although a specific time was not provided.No additional information was provided.
 
Manufacturer Narrative
A visual, functional, and dimensional inspection was performed on the returned device.The reported deflation problem was not confirmed.The reported difficult to advance could not be tested as it was based on operational circumstances.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 other incidents.The investigation was unable to determine a conclusive cause for the reported deflation problem; however, factors that may contribute to deflation problems include, but are not limited to, inflation/deflation technique, contrast concentration, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.It is possible the balloon was not allowed sufficient time to deflate before an attempt was made to withdrawal the device, resulting in the reported deflation problem; however, this cannot be confirmed.In addition, it is likely the reported difficult to advance was due to interaction with the calcified anatomy during advancement as resistance was noted.Further manipulation of the device during advancement and retraction likely contributed to the noted stretching and bunching to the inner/outer member in addition to the stretched guide wire exit notch.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.Na.
 
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Brand Name
XIENCE PROA 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
MDR Report Key12354182
MDR Text Key267681611
Report Number2024168-2021-07387
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,foreig
Type of Report Initial,Followup
Report Date 09/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/18/2024
Device Catalogue Number1128400-23
Device Lot Number1050361
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/03/2021
Initial Date Manufacturer Received 08/05/2021
Initial Date FDA Received08/23/2021
Supplement Dates Manufacturer Received09/21/2021
Supplement Dates FDA Received09/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
7 FR GUIDE CATHETER; 7 FR GUIDE CATHETER
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