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

Model Number	1804250-12
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional device is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified unspecified lesion.The ht balance middleweight (bmw) elite guide wire became stuck with the 2.5x12mm xience skypoint stent delivery system (sds) during advancement.The guide wire and the sds were removed as one unit.Another xience skypoint and bmw elite was used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay reported.No additional information was provided.
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified unspecified lesion.The ht balance middleweight (bmw) elite guide wire became stuck with the 2.5x12mm xience skypoint stent delivery system (sds) during advancement.The guide wire and the sds were removed as one unit.Another xience skypoint and bmw elite was used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported difficult to advance/position and difficult to remove from the guide wire were confirmed.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 was unable to determine a conclusive cause for the reported difficulties; however, difficult to advance/position and difficult to remove (guide wire resistance) may be attributed to several factors including, but are not limited to, product placement technique, guiding catheter support, inner diameter of guide wire lumen, outer diameter of the guide wire, condition of the guide wire, damage to the catheter or accumulation of blood or contrast.In this case, it is possible that a buildup of procedural contaminants may have contributed to the reported difficult to advance and difficult to remove (guide wire resistance); however, this cannot be confirmed.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: 13711287
• Report Number: 2024168-2022-02377
• Device Sequence Number: 5956919
• Product Code: NIQ
• UDI-Device Identifier: 08717648233067
• UDI-Public: 08717648233067
• Combination Product (Y/N): Y
• Initial Reporter State: PR
• 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): 04/28/2022

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: 09/14/2023
• Device Model Number: 1804250-12
• Device Catalogue Number: 1804250-12
• Device Lot Number: 1090841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2021
• 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: HT BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE.
• Patient Age: 69 YR
• Patient Sex: Male