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

Model Number	1804275-38
Medical Device Problem Codes	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	07/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.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 other incidents.It was reported that negative pressure was held for 3 to 5 seconds before attempting to remove the balloon after deployment of the stent.It should be noted that the xience skypoint, everolimus eluting coronary stent system, instructions for use (ifu) states: deflate the balloon by pulling negative pressure on the inflation device.Larger and longer balloons will take more time (up to 30 seconds) to deflate than smaller and shorter balloons.Confirm balloon deflation under fluoroscopy and wait 10 ¿ 15 seconds longer.It is unknown if the ifu deviation contributed to the reported event.The investigation was unable to determine a conclusive cause for the reported difficult to remove.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat the left anterior descending (lad) coronary artery with moderate calcification and no tortuosity.The 2.75x38 mm xience skypoint stent had been deployed with 2 inflations to 12 atmospheres (atm) and negative pressure was held for 3-5 seconds to deflate the balloon.The balloon of the delivery system was stuck to the stent.The balloon was re-inflated and pulled to negative again and wiggled aggressively and it was able to disengage from the stent and be removed.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.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
• MDR Report Key: 12226549
• Report Number: 2024168-2021-06474
• Device Sequence Number: 11093497
• Product Code: NIQ
• UDI-Device Identifier: 08717648233203
• UDI-Public: 08717648233203
• 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
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/26/2021

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: 04/11/2023
• Device Model Number: 1804275-38
• Device Catalogue Number: 1804275-38
• Device Lot Number: 1040741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR