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

Model Number	1804275-18
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was received.Investigation is not yet complete.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 90% stenosed, moderately calcified and moderately tortuous vessel in the mid left anterior descending (mlad) artery.Dilatation of the mlad and intravascular ultrasound (ivus) was performed.An asahi sion blue guide wire was inserted into the distal tip of the 2.75x18mm xience skypoint stent delivery system (sds) and the sds was advanced, however, resistance was felt with the guide wire.A blood clot was noted on the guide wire prior to use of the sds and while the sds was advanced over the guide wire, the blood clot was also advanced together with the sds.The sds was advanced with the resistance noted, however, the sds was stuck in front of the y-connector.The sds was attempted to be removed with not much force once to wipe the blood clot off but the distal tip of the sds got separated during removal.The sds was removed from the guide wire and the broken distal tip that remained on the guide wire was also removed by simply withdrawing.A same size non-abbott stent was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported tip separation was confirmed.The reported difficulty to advance and difficulty to remove could not be confirmed due to the condition the device was received for evaluation.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 operational context of the procedure as it is likely the device interacted with the guide wire in combination with the reported blood clot during advancement causing the reported difficulty to advance.The device was then removed; however, continued interaction with the guide wire and/or reported blood clot caused difficulty removing resulting in the reported tip separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: medical device problem code 2017/excessive force and against resistance removed.

• 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: 13793222
• Report Number: 2024168-2022-02729
• Device Sequence Number: 3906829
• Product Code: NIQ
• UDI-Device Identifier: 08717648233166
• UDI-Public: 08717648233166
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2022

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: 09/10/2023
• Device Model Number: 1804275-18
• Device Catalogue Number: 1804275-18
• Device Lot Number: 0090441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2020
• 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: SION BLUE.
• Patient Sex: Unknown