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

Model Number	1804300-18
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right coronary artery (rca).An unspecified guide wire (gw) was in the patient anatomy and a 3.00x18mm xience skypoint drug eluting stent (des) was advanced onto the guide wire.Resistance was noted and the des was removed without difficulty.The guide wire was re-saturated and the skypoint des was re-advanced; however, it was noted that the stent had dislodged; it had moved back on the delivery system, fully off the balloon, but remaining on the delivery system.The skypoint des was not in the anatomy at the time the stent dislodged.A second xience skypoint was used over the same guide wire to successfully complete the procedure.There were no reported adverse patient effects and no clinically significant delays in the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the initially filed report, the following information was received: the des was introduced into the guiding catheter but not into the vessel before removing and re-advancing.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported stent dislodgement was confirmed.The reported difficulty to advance could not be confirmed due to the condition the device was received 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 similar incidents from this lot.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
• Common Device Name: 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: 16499259
• Report Number: 2024168-2023-02329
• Device Sequence Number: 15105983
• Product Code: NIQ
• UDI-Device Identifier: 08717648233241
• UDI-Public: 08717648233241
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: 1804300-18
• Device Catalogue Number: 1804300-18
• Device Lot Number: 2062241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2023
• Supplement Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown