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

Catalog Number 1128350-38

Device Problem Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.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 the procedure, the 3.5x38 mm xience proa balloon could not be inflated to be deploy the stent in the target lesion.No resistance was noted during advancement.The stent delivery system was removed and the procedure was completed with another xience stent.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.The physician could not remember if the device had been prepped correctly.No additional information was provided.

Manufacturer Narrative

B3, b6: dates were estimated.The device was returned for analysis.The reported activation failure including expansion failures/difficult to deploy was able to be 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.As there was no report of a leak during preparation for use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that inadvertent mishandling/over torqueing during connection to the inflation device resulted in the noted longitudinal crack on the proximal end of the hub; thus resulting in the reported activation failure including expansion failures.There is no indication of a product quality issue with respect to manufacture, design or labeling.D4: expiration date.

• Brand Name: XIENCE PROA
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10443091
• MDR Text Key: 204041912
• Report Number: 2024168-2020-07034
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2023
• Device Catalogue Number: 1128350-38
• Device Lot Number: 0052241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Date Manufacturer Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1