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

Catalog Number 1070250-18

Device Problems Deflation Problem (1149); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Exemption number (b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow-up will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat an 80% stenosed, moderately calcified lesion in the mid right coronary artery (rca).Reportedly, the device was not air aspirated outside the anatomy prior to use.Pre-dilatation was performed and the 2.5x18 mm xience xpedition stent delivery system was introduced to the artery and taken to the lesion for deployment.While deploying the stent, the physician noted difficulty deflating the stent balloon.The balloon was inflated again to 14 atmospheres (atm) and then held negative for 15 seconds, partially deflating the balloon in order to be removed.The stent was successfully deployed.There were no reported adverse patient effects and there was no reported clinically significant delay in the procedure.The physician expressed concern about the stent delivery system.No additional information was provided.

Event Description

Additional information received indicates that the device was not prepped.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001.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 identified no similar incidents from this lot.It was reported xience xpedition device was not prepped prior to use.It should be noted that the xience xpedition everolimus eluting coronary stent system instruction for use lists system preparation to be performed prior to delivery procedure.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device had difficulty deflating due to the reported instruction for use deviation related to not prepping the device prior to use.The device preparation process removes the air from the inflation lumen, it is likely air in the inflation lumen caused and/or contributed to the reported deflation issues.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE XPEDITION
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8822903
• MDR Text Key: 152085856
• Report Number: 2024168-2019-10305
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• 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: 09/09/2019

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 Date: 01/18/2022
• Device Catalogue Number: 1070250-18
• Device Lot Number: 9011441
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/03/2019
• Initial Date FDA Received: 07/24/2019
• Supplement Dates Manufacturer Received: 08/22/2019
• Supplement Dates FDA Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1