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

Catalog Number 1804300-15

Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)

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

Event Date 02/09/2024

Event Type  malfunction  

Manufacturer Narrative

H6: 2017 device code clarifier- excessive force.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 moderately calcified and mildly tortuous left anterior descending coronary artery (lad).A 3.0x15mm xience skypoint stent delivery system (sds) was advanced into the guide liner (guide extension 5f) however, the delivery system became stuck.When attempting to pull out the sds, resistance was met and force was applied.The shaft broke and at a point outside of the y-connector; therefore, everything was removed together.Another 2.5x15mm skypoint was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported shaft separation was confirmed.The reported difficulty to advance and difficulty to remove could not be replicated in a testing environment as it was related to operational context of the procedure.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 that when attempting to pull out the sds, resistance was met and force was applied.The shaft broke and at a point outside of the y-connector; therefore, everything was removed together.It should be noted that the xience skypoint everolimus eluting coronary stent system instruction for use states: if unusual resistance is felt before the stent exits the guiding catheter, do not force passage.Maintain guide wire placement across the lesion and remove the delivery system and guiding catheter as a single unit.In this case, the instructions for use deviation related to the use of force does not appear to have caused the reported difficulties.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.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
• 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: 18813321
• MDR Text Key: 336619310
• Report Number: 2024168-2024-02627
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233234
• UDI-Public: 08717648233234
• 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,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1804300-15
• Device Lot Number: 3101641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2023
• 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
• Treatment: GUIDE LINER. 5F GUIDE EXTENSION.
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 49 KG