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

Catalog Number 1804250-18

Device Problems Difficult to Remove (1528); Material Rupture (1546); Difficult to Advance (2920); Activation Failure (3270)

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 the mid left anterior descending (lad) coronary artery with heavy calcification, mild tortuosity and 90% stenosis.A guide wire was delivered and two non-abbott balloons were used for pre-dilatation.Then, the 2.5x18 mm xience skypoint stent delivery system (sds) was advanced to the lesion with resistance noted with the lesion and deployment was attempted.The device was inflated once to 2 atmospheres and it was noted that the balloon was ruptured.The sds was attempted to be removed but there was resistance with the anatomy.A pinhole rupture was noted.A guide catheter which was already present inside the anatomy was advanced to mount the stent and then the sds was pulled strongly and the device was removed together with the guiding catheter.Two non-abbott stents were deployed to complete the procedure.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.Upon removal from the anatomy the sds was inspected and a pinhole rupture was noted.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: 18915415
• MDR Text Key: 337800183
• Report Number: 2024168-2024-03377
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233081
• UDI-Public: 08717648233081
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1804250-18
• Device Lot Number: 3082141
• 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: 08/14/2023
• 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