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

Model Number	1804250-18
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2022
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.
Event or Problem Description
It was reported that the procedure was to treat a de novo lesion located in the mid left anterior descending coronary artery that was both mildly calcified and tortuous and 90% stenosed.After the lesion was predilated, the 2.5x18mm xience skypoint stent system was advanced to the lesion and during stent deployment, a leak was noted, so high-speed inflation was performed, successfully implanting the stent.After removal of the stent delivery system, a pinhole rupture was noted on the tip of the device.Post-dilatation was performed with an nc balloon and intravascular ultrasound (ivus) confirmed the stent was well apposed to the vessel wall.There was no adverse patient effect or a clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and functional inspection was performed on the returned device.The reported leak / splash and material rupture 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.Factors that may contribute to a leak include, but are not limited to, damage to the inflation lumen, loose connection with the indeflator, and/or damage to the balloon.Factors that may contribute to a material rupture include, but are not limited to, material damage, inflation technique, interactions with other devices, lesion calcification and tortuosity, and/or insufficient preparation prior to use.In this case, it is possible that the stent delivery system (sds) interacted with an accessory device and/or the mildly calcified, mildly tortuous, and 90% stenosed lesion during advancement, contributing to the reported material rupture and subsequent leak; 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: 14848821
• Report Number: 2024168-2022-07014
• Device Sequence Number: 11970137
• Product Code: NIQ
• UDI-Device Identifier: 08717648233081
• UDI-Public: 08717648233081
• 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: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2022

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: 09/19/2024
• Device Model Number: 1804250-18
• Device Catalogue Number: 1804250-18
• Device Lot Number: 109104A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2022
• Supplement Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2021
• 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