MAUDE Adverse Event Report: ABBOTT VASCULAR RX XIENCE XPEDITION 48; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1078250-48

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a lesion with heavy calcification in the right coronary artery (rca).Pre-dilatation was performed.Then a 2.5 x 48mm xience xpedition stent delivery system (sds) was advanced; however, the sds failed to cross the target lesion due to the heavily calcified lesion.Therefore, an extension catheter was used, but the sds could not be advanced with the extension catheter.It was possible that the inside of the extension catheter was deformed.The sds was removed with resistance due to the anatomy.Another unspecified device was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.

Manufacturer Narrative

Device code 2017: improper or incorrect procedure or method.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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to the operational context of the procedure, as it is likely the device interacted with the heavily calcified anatomy during advancement, as resistance was noted, causing the reported failure to advance.Interaction with the guide catheter during advancement likely contributed to the reported difficult to advance/position, as the physician noted that the inside of the extension catheter may have been deformed.Further interaction with the challenging anatomy during retraction, as resistance was again noted, likely contributed to the reported difficult to remove.It should be noted that the xience xpedition, everolimus eluting coronary stent system instructions for use (ifu) states: an unexpanded stent may be retracted into the guiding catheter one time only.An unexpanded stent should not be reintroduced into the artery once it has been pulled back into the guiding catheter.Subsequent movement in and out through the distal end of the guiding catheter should not be performed, as the stent may be damaged when retracting the undeployed stent back into the guiding catheter.It is unknown if the ifu deviation contributed to the reported event.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.Na.

Event Description

N/a.

• Brand Name: RX XIENCE XPEDITION 48
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10465402
• MDR Text Key: 204715514
• Report Number: 2024168-2020-07202
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2022
• Device Catalogue Number: 1078250-48
• Device Lot Number: 9111541
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1