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

Catalog Number 1078250-48

Device Problems Difficult to Advance (2920); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2020

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.

Event Description

It was reported that the procedure was to treat a mildly tortuous and moderately calcified lesion in the mid left anterior descending (lad) artery.The 2.50x48mm rx xience xpedition stent delivery system (sds) was advanced to the lesion with resistance noted.When pressurized to 14 atmospheres (atm), the balloon would not inflate.Pressure was increased to 16 atm however the balloon still would not inflate.The sds was removed and replaced with a new xpedition to complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported activation failure including expansion failures/failure to deploy was able to be confirmed.The reported difficult to advance was unable to be replicated in a testing environment as it was based on operational circumstances.A tear in the outer member was observed proximal to the proximal seal.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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement resistance was met with lesion resulting in the reported difficult to advance.Interaction and/or manipulation of the device resulted in the noted tear in the outer member, thus resulting in the reported activation failure/failure to deploy.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 9969055
• MDR Text Key: 188097900
• Report Number: 2024168-2020-03708
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2023
• Device Catalogue Number: 1078250-48
• Device Lot Number: 0020441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2020
• Date Manufacturer Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1