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

Model Number	1804225-23
Medical Device Problem Codes	Failure to Fold (1255); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
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 heavily calcified, mildly tortuous lesion in the left anterior descending (lad) artery.A xience skypoint drug eluting stent (des) was implanted at the target lesion without issue.During removal of the device from the anatomy, the balloon did not re-wrap as expected and was difficult to pull back into the guiding catheter, in order to remove the delivery system from the anatomy; however, it was removed successfully applying a little force.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
H6: medical device problem code 2017 incorrect removal.A visual inspection was performed on the returned device.The reported difficult to remove could not be tested due to the device condition.The reported failure to fold was not confirmed as the balloon was loosely folded, indicating the balloon was subjected to pressurization.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 identified no similar incidents from this lot.It was reported that the balloon was difficult to pull back into the guiding catheter and force was used to successfully remove the sds.The guide catheter and stent delivery system were removed separately.It should be noted that the xience skypoint instructions for use (ifu) states: after successful withdrawal of the balloon from the deployed stent, should any resistance be felt at any time when withdrawing the stent delivery system or post-dilatation balloon into the guiding catheter, remove the entire system as a single unit.In this case, it is unknown if the ifu deviation contributed to the reported event.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
Subsequent to the initial medwatch report, it was confirmed that the stent delivery system was removed on its own and not with the guiding catheter as a single unit.No additional information was provided.

• 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: 13879860
• Report Number: 2024168-2022-03095
• Device Sequence Number: 12080279
• Product Code: NIQ
• UDI-Device Identifier: 08717648233012
• UDI-Public: 08717648233012
• Combination Product (Y/N): Y
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 05/06/2022

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: 09/02/2023
• Device Model Number: 1804225-23
• Device Catalogue Number: 1804225-23
• Device Lot Number: 1082641
• 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: 02/28/2022
• Supplement Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2021
• 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
• Patient Sex: Unknown