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

Catalog Number 1800250-23

Device Problems Difficult or Delayed Activation (2577); Difficult to Advance (2920); Material Too Soft/Flexible (4007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/19/2021

Event Type  Injury  

Manufacturer Narrative

The stent remains in patient.The device will not be returned for evaluation.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 to treat the proximal left anterior descending (lad) coronary artery.The 2.50x23 mm xience skypoint stent delivery system was deployed at 16 atmospheres (atm) for 30 seconds; however, the stent was in an hourglass shape (pinched in the middle).Therefore a 2.75x15 mm nc trek balloon dilatation catheter (bdc) was advanced with difficulty due to the previously implanted stent and inflated to 14 atm for almost 14 seconds.The stent was now well apposed and the procedure was completed.There were no adverse patient sequela reported and there was no reported clinically significant delay in the procedure.The physician also stated that the xience skypoint radial force is less than xience sierra.No additional information was provided.

Manufacturer Narrative

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 other incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficult or delayed activation; however, factors that may contribute to difficult or delayed activation include, but are not limited to; damage to the device, contamination in the inflation lumen, patient anatomical morphology, patient disease state, inflation technique, contrast dilution, and inadequate connection to the inflation device.The reported material too soft/flexible (hour glass shape) appears to be related to operational context of the procedure as it is likely the difficulty to deploy the stent caused the reported stent state of material too soft/flexible (hour glass shape).Post dilation was performed with a balloon dilation catheter (bdc), the bdc met resistance with the hour glass shaped stent causing the reported difficulty to advance (crossability).The reported treatment appears to be related to operational context.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12591665
• MDR Text Key: 275219400
• Report Number: 2024168-2021-09002
• 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: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1800250-23
• Device Lot Number: 1060241
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2.75X15 MM NC TREK BALLOON DILATATION CATHETER; 2.75X15 MM NC TREK BALLOON DILATATION CATHETER
• Patient Outcome(s): Required Intervention