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

Catalog Number	1804400-23
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional nc trek neo device referenced in b5 is filed under separate medwatch report number.D4: the udi is unknown due to the part/lot number was not provided.
Event or Problem Description
It was reported that procedure was to treat a 50% stenosed de novo lesion in the in the proximal left anterior descending (plad) artery with heavy calcification.The 4mm xience stent was implanted.The 4x8mm nc trek neo balloon dilatation catheter (bdc) was used for post dilatation; however, the balloon ruptured at 8 atmospheres (atm).Therefore, the bdc was removed from the patient and the stent was noted to be indented.A non-abbott balloon was used for further post-dilation of the stent indentation.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Event or Problem Description
It was reported that procedure was to treat a 50% stenosed de novo lesion in the in the proximal left anterior descending (plad) artery with heavy calcification.The 4mm xience stent was implanted.The 4x8mm nc trek neo balloon dilatation catheter (bdc) was used for post dilatation; however, the balloon ruptured at 8 atmospheres (atm).Therefore, the bdc was removed from the patient and the stent was noted to be indented.A non-abbott balloon was used for further post-dilation of the stent indentation.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 difficult or delayed activation.The reported treatment appears to be related to 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: 18904306
• Report Number: 2024168-2024-03310
• Device Sequence Number: 18425794
• 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: 2024
• 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): 03/20/2024

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: 05/24/2026
• Device Catalogue Number: 1804400-23
• Device Lot Number: 3060641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/23/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2023
• 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: NC TREK NEO RX 4.00 X 8MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown