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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 1128275-15
Device Problems Leak/Splash (1354); Product Quality Problem (1506); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/02/2021
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 during preparation of the 2.75x15 mm xience proa stent delivery system, there was damage noted to the catheter and air was escaping from that area.There was no reported device use or patient involvement.A new xience stent was used to complete the procedure.There was no reported clinically significant delay.No additional information was provided.
 
Manufacturer Narrative
The device was returned for analysis.The reported shaft tear and leak were confirmed.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 from this lot.The investigation was unable to determine a conclusive cause for the reported torn material; however, factors that may contribute to tears (torn guide wire notch) include, but are not limited to, handling, material damage and interactions with other devices.The reported leak appears to be related to operational context as the torn guide wire notch likely resulted in the leak.It should be noted that the returned device appeared to be inserted although the account indicated the device was not used.It is possible that interaction due to handling and/or manipulation of the device while loaded on the guide wire caused the reported tear (torn guide wire notch); however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: corrected patient code 2645 to 2199, removed device code 1506.
 
Event Description
It was reported that during preparation of the 2.75x15 mm xience proa stent delivery system, there was damage noted to the catheter and air was escaping from that area.There was no reported device use or patient involvement.A new xience stent was used to complete the procedure.There was no reported clinically significant delay.Subsequent to the initially filed report, the following information was provided: there was a visible hole in the catheter area and it was assumed that the balloon would not inflate.Inflation was not attempted and the device was not used in the patient.However, qat analysis identified that the device had been inserted at least onto a guide wire.No additional information was provided.
 
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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 Key12078941
MDR Text Key259416109
Report Number2024168-2021-05484
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 08/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/20/2022
Device Catalogue Number1128275-15
Device Lot Number9110561
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2021
Date Manufacturer Received07/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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