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

Model Number 1804350-28

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Malposition of Device (2616); Difficult to Advance (2920); Material Deformation (2976)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/04/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for evaluation, the device was reportedly discarded.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 a lesion in an saphenous vein graft to obtuse marginal (svg to om) artery.A 3.50 x 28mm xience skypoint stent delivery system(sds) was attempted to be advanced to the target lesion; however, the stent did not reach the target lesion due to anatomical challenges.Therefore, a decision was made to deploy the stent in healthy tissue only, proximal to the target lesion.Then during removal of the sds, the balloon and an unspecified wire became stuck with the stent.Force was applied and the devices were removed; however, the stent became deformed.Attempts were made to cross with an additional unspecified balloon to the implanted stent for post-dilation; however, a balloon was unable to cross the stent.The procedure ended at this point and the patient was discharged.On (b)(6) 2022, the patient was re-admitted and underwent an extensive catheter procedure in order to dilate the deformed stent and then treat the target lesion.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.It was reported that force was applied to the stent delivery system (sds) during removal of the device from the anatomy.It should be noted that the xience skypoint instructions for use states: applying excessive force to the delivery system can potentially result in loss or damage to the stent and/or delivery system components.In this case, it is unknown if the ifu deviation contributed to the reported event.The investigation determined the reported failure to advance, malposition of device, difficult to remove, material deformation, and subsequent treatments appear to be related to the operational context of the procedure.Additionally, the investigation was unable to determine a conclusive cause for the reported difficult to advance.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: 13967294
• MDR Text Key: 288303235
• Report Number: 2024168-2022-03413
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233425
• UDI-Public: 08717648233425
• 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: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2023
• Device Model Number: 1804350-28
• Device Catalogue Number: 1804350-28
• Device Lot Number: 1072841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• 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 Outcome(s): Required Intervention; Hospitalization