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

Model Number	1804300-33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Perforation of Vessels (2135); Pericardial Effusion (3271)
Date of Event	08/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that procedure was to treat a lesion in the proximal left anterior descending (lad) artery.A 6 french sheath was used.The bmw guidewire (gw) was advanced with difficulty; however, was able to be positioned into the distal vessel.For pre-dilatation, the 3.00x12mm nc trek balloon dilatation catheter (bdc) was advanced and the balloon was inflated one time to 12 atmospheres (atm); however, the mid segment did not expand due to eccentric calcification.The bdc was removed from the patient and replaced with another nc trek balloon to complete pre-dilatation.Then, the 3.00x33nn xience skypoint stent delivery system (sds) was advanced and the stent was deployed; however, some contrast extravasation from the mid lad was noted.Therefore the balloon of the sds was re-inflated for 5 minutes, but the patient continued to bleed.Therefore, the 2.80x16mm rx graftmaster covered stent was advanced to the perforation with difficulty and deployed at 15 atmospheres (atm), but the the stent did not completely cover the perforation.The perforation was treated with a non-abbott stent.The patient experienced chest pain post procedure.There was no reported clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of angina, pericardial effusion and perforation are listed in the xience skypoint, everolimus eluting coronary stent system (eecss), electronic instructions for use (ifu) as known patient effects of coronary stenting procedures.Based on the information reviewed, there is no indication of a product quality issue.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.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: 15440885
• Report Number: 2024168-2022-09822
• Device Sequence Number: 14848245
• Product Code: NIQ
• UDI-Device Identifier: 08717648233272
• UDI-Public: 08717648233272
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1804300-33
• Device Catalogue Number: 1804300-33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 68 KG