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

Catalog Number 1804275-18

Device Problems Material Separation (1562); Difficult to Advance (2920)

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

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was to treat a lesion located in the 1st diagonal in the left anterior descending (lad) coronary artery that was heavily calcified.Reportedly, the nc trek neo rx 3.00 x 12mm was advanced first in the distal lad.Then, the xience skypoint des 2.75 x 18 rx us stent delivery system was unable to advance out of the guide catheter.The physician lost guide engagement and wire position, and pulled both devices into the guide catheter.Once the guide catheter was re-engaged, and the physician had wire placement, the nc trek neo was re-advanced into the distal lad (but not inflated).The sds was unable to advance, with resistance.Then the sds was removed and noticed that the stent had separated from the shaft outside the patient.The nc trek neo appeared to be kinked on the shaft.Both devices were not able to be used and set aside.A new stent and balloon of the same size were opened and successfully used.There were no reported adverse patient effects 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: 18899111
• MDR Text Key: 337620135
• Report Number: 2024168-2024-03291
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233166
• UDI-Public: 08717648233166
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1804275-18
• Device Lot Number: 3062841
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 95 KG