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

Model Number 1804225-23

Device Problems Failure to Fold (1255); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2022

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 288998530
• Report Number: 2024168-2022-03095
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233012
• UDI-Public: 08717648233012
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1