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

Catalog Number	1804400-23
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat a 90% stenosed lesion in the mid right coronary artery (mrca) with mild calcification and mild tortuosity.The 4.0x23mm xience skypoint stent delivery system (sds) was advanced to the target lesion and the balloon was inflated twice at 14 atmospheres to deploy the stent.During deflation, the balloon took longer than usual deflate; however, was it was able to be completely deflated.The sds was removed from the patient and intravascular ultrasound (ivus) confirmed the stent was implanted without issue.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual, dimensional, and functional inspection was performed on the returned device.The reported deflation problem was not 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 deflation problem; however, factors that may contribute to deflation problems include, but are not limited to, deflation technique, contrast concentration, contamination in the inflation lumen, damage to the guide wire and/or inflation lumen.It should be noted that the japan xience skypoint, everolimus eluting coronary stent system, instructions for use (ifu) specifies: deflate the balloon by pulling negative slowly for 30 seconds on the inflation device.In this case, it is possible the balloon was not allowed sufficient time to deflate before an attempt was made to remove the device, resulting in the reported deflation problem; 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: 17558020
• Report Number: 2024168-2023-08896
• Device Sequence Number: 11658665
• Product Code: NIQ
• UDI-Device Identifier: 08717648233494
• UDI-Public: 08717648233494
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 10/12/2023

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: 04/26/2025
• Device Catalogue Number: 1804400-23
• Device Lot Number: 2042141
• 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: 07/24/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2022
• 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: HYPERION GUIDE CATHETER; SION GUIDE WIRE
• Patient Sex: Unknown