MAUDE Adverse Event Report: ABBOTT VASCULAR INC. XIENCE SKYPOINT¿; CORONARY DRUG-ELUTING STENT

Model Number	1804300-23
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the production records and the corrective and preventive actions (capa) database was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation was unable to determine a conclusive cause for the reported material rupture.It was reported that a rupture was observed during inflation of the stent delivery system (sds).Factors that may contribute to a material rupture include, but are not limited to, inadequate balloon integrity, interaction with challenging anatomy, interaction with accessory devices, and/or inflating above the rated burst pressure.Based on the information provided and because the device was not returned for analysis, it is unknown what may have caused the reported material rupture.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified, moderately tortuous and 90% stenosed proximal left anterior descending coronary artery.Rotablation was performed using a 1.25mm non-abbott rotational atherectomy device, followed by pre-dilatation with a 2.5x10mm non-abbott balloon dilatation catheter (bdc).The 3.0x23mm xience skypoint stent delivery system (sds) was prepared per instructions for use and advanced; however, a pinhole rupture occurred when the balloon was inflated to 6 atmospheres.This was attributed to the remaining calcification post ablation.The stent was retrieved without issue.Additional dilatation was performed with a 2.75x10mm non-abbott bdc.A new 2.75x23mm xience skypoint stent was advanced and successfully implanted.Post-dilation was performed using a 3.0x12mm nc trek neo bdc, and the procedure was completed without issues.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE SKYPOINT¿
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 20802628
• Report Number: 2024168-2024-14069
• Device Sequence Number: 9830725
• Product Code: NIQ
• UDI-Device Identifier: 08717648233258
• UDI-Public: (01)08717648233258(17)260511(10)3052241
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 11/27/2024

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: 05/11/2026
• Device Model Number: 1804300-23
• Device Catalogue Number: 1804300-23
• Device Lot Number: 3052241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2023
• 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
• Patient Sex: Unknown