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

Model Number	1804325-18
Medical Device Problem Codes	Material Rupture (1546); Difficult to Advance (2920); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified, moderately tortuous distal left circumflex artery that is 90% stenosed.Ablation was performed and a 2.75x10mm balloon was used to pre-dilate the lesion several times.A 3.25x18mm xience skypoint was advanced to the lesion; however, resistance was felt with anatomy.When attempting to deploy the stent the stent balloon ruptured at 6 atmospheres.The stent remained stationary on the delivery system and was removed.A 2.75x10mm balloon performed additional dilatation and a 3.0x18mm xience skypoint was deployed.A 3.25x12mm nc trek neo was used for post dilatation to complete the procedure.There was no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Electronic lot history record (elhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other incidents from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the heavily calcified, moderately tortuous and 90% stenosed anatomy resulting in the reported difficult to advance.Interaction with the heavily calcified, moderately tortuous and 90% stenosed anatomy likely compromised the balloon material such that during inflation resulted in the reported material rupture and the reported activation failure.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 19723690
• Report Number: 2024168-2024-08176
• Device Sequence Number: 8275261
• Product Code: NIQ
• UDI-Device Identifier: 08717648233326
• UDI-Public: (01)08717648233326(17)261011(10)3102041
• 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): 07/11/2024

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 Model Number: 1804325-18
• Device Catalogue Number: 1804325-18
• Device Lot Number: 3102041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2023
• 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