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

Model Number	1804275-18
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Codes	Air Embolism (1697); Cardiogenic Shock (2262); Syncope/Fainting (4411)
Date of Event	02/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The delivery system was received.The stent implant remains in the patient.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 to the right coronary artery (rca) and the proximal left anterior descending artery (plad).The rca was treated first with an unspecified device.The 2.75x18mm xience skypoint stent delivery system was advanced and attempted to be inflated; however, under cine the shape appeared to be dog-boned.The pressure was attempted to be increased from 6 atmospheres, but the gage pressure of an non-abbott indeflator would not increase.A leak occurred from the distal end of the delivery system as the indeflator was being used.The stent was deployed and patient went into shock and a intra-aortic balloon pump (iabp) was used as well as extracorporeal membrane oxygenation (ecmo).Another unspecified balloon was used expand the deployed stent firmly into the vessel wall.Additionally, an air embolism occurred and unknown guiding catheter was inserted deeply to draw air and recover the flow.The patient regained consciousness and no clinically significant delay was reported.No additional information was provided.
Additional Manufacturer Narrative
A visual and functional inspection was performed on the returned device and the reported leak and inflation issue 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 and/or complaints reported from this lot.The reported patient effects of air embolism and shock are listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the noted tears.It may be possible that the guide wire used in the procedure was damaged causing the tears on the inner member during loading of the guide wire; however, this could not be confirmed.Although a conclusive cause for the noted tears was unable to be concluded, the reported leak, inflation issue appears to be related to operation circumstances of the procedure as it is likely that the tears on the inner member resulted in the leak and inflation issue.The patient effects of shock, syncope, and air embolism and the treatment all appear to be related to operational context of the procedure.Factors that may contribute to difficulty inflating the device may include, but are not limited to, damage to the device, contamination in the inflation lumen, patient anatomical morphology, patient disease state, inflation/deflation technique, contrast dilution, inadequate connection to the inflation device, and/or accessory device support.To help ensure this difficulty is not related to a manufacturing issue, all balloon catheters are visually inspected for damage in manufacturing.In this case, the device was prepped prior to use with no issue/ leak noted, which would suggest that the device was not damaged prior to use.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: 13579207
• Report Number: 2024168-2022-01859
• Device Sequence Number: 5526721
• Product Code: NIQ
• UDI-Device Identifier: 08717648233166
• UDI-Public: 08717648233166
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 1804275-18
• Device Catalogue Number: 1804275-18
• Device Lot Number: 1012241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SHEEN MAN INDEFLATOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown