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

Model Number	1804250-15
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a lesion in the proximal ostial circumflex with mild calcification, heavy tortuosity and 90 degree angle.The 2.5x15mm xience skypoint stent delivery system (sds) failed to cross the lesion due to the 90-degree angle.The sds was removed and the stent was checked.A 6 french (fr) guideliner was advanced and the sds was re-advanced; however, again the sds would not advance past the turn (90-degree angle).A lot of resistance with the guideliner was felt during removal, however, the sds was removed as a single unit.The sds was yanked out and the stent dislodged.The left ventricle was checked but the stent was not there and instead found to be in the descending aorta.A snare was used to successfully remove the dislodged stent.There was no adverse patient sequela.There was no clinically significant delay in the procedure.No additional information was provided.
Additional 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.
Additional Manufacturer Narrative
The device was not returned 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 did not indicate a lot specific quality issue.It should be noted that the xience skypoint everolimus eluting coronary stent system instruction for use states: an unexpanded stent may be retracted into the guiding catheter one time only.An unexpanded stent should not be reintroduced into the artery once is has been pulled back into the guiding catheter.Subsequent movement in and out through the distal end of the guiding catheter should not be performed, as the stent may be damaged or dislodged during retraction back into the guiding catheter.Additionally, it should be noted that the xience skypoint everolimus eluting coronary stent system instruction for use states: applying excessive force to the delivery system can potentially result in loss of or damage to the stent and/or delivery system components.In this case, it is unknown if the instruction for use (ifu) deviations related to re-insertion and force during removal caused and/or contributed to the reported event.The investigation determined the reported difficulties and treatment 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: 16097050
• Report Number: 2024168-2023-00098
• Device Sequence Number: 6511967
• Product Code: NIQ
• UDI-Device Identifier: 08717648233074
• UDI-Public: 08717648233074
• 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): 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/22/2024
• Device Model Number: 1804250-15
• Device Catalogue Number: 1804250-15
• Device Lot Number: 2051241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6FR GUIDELINER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 76 KG