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

Catalog Number 1800275-28

Device Problems Difficult or Delayed Activation (2577); 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 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).The reported treatment appears to be related to operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat a mid left anterior descending artery.The lesion was pre-dilated with non-abbott balloons at 8 atmospheres (atm).The 2.75x28mm xience skypoint stent delivery system was deployed at 12 atm; however, the stent was in a hourglass shape.A 3.0x15mm non-abbott balloon was used to post dilate and fully appose the stent into the vessel wall.A 2.5x12mm xience sierra stent was deployed at 12 atm for 22 seconds overlapping the previous implanted stent.Post dilatation was performed with a 2.5x15mm nc trek balloon dilatation catheter at 18 atm for 6 seconds.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12623670
• MDR Text Key: 276134546
• Report Number: 2024168-2021-09171
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: SA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1800275-28
• Device Lot Number: 1060341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention