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

Model Number	1804250-28
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Device Dislodged or Dislocated (2923); Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat the left anterior descending (lad) coronary artery.When the 2.5x28 mm xience skypoint stent delivery system (sds) attempted to deploy the stent, the stent would not release from the delivery system.During an attempt to remove the device with a snare, the balloon ruptured and the stent became lodged in the femoral artery.The patient was transferred to another hospital where the stent was removed.The patient is stable.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
Subsequent to the initially filed report it was reported that the lesion was heavily calcified.The balloon rupture was noted during the first inflation of the sds to approximately 4-6 atmospheres.The stent appeared flared and there was resistance during removal into the guiding catheter so all devices were removed as a single unit and the stent dislodged during the attempt to pull it back into the guiding catheter.The stent was removed via cut down at the other hospital.Additionally, medwatch mw5165908 received which states: coronary stent attempted to be implanted, the stent balloon burst at initial inflation, resulting in a free-floating stent.The stent was not able to be retrieved.The patient had to be transferred to a vascular surgeon to have the stent removed.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the information provided, a definitive cause for the reported material rupture issue could not be determined.The reported material deformation, difficulty to remove, stent dislodgement and treatment appear to be related to operation context of the procedure.Based on the 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.D9: corrected device available for evaluation from yes to no.H6: correction: medical device problem code 3270 was removed.Attached medwatch report #mw5165908.

• 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 UNK ; EI UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 21394318
• Report Number: 2024168-2025-01761
• Device Sequence Number: 8273620
• Product Code: NIQ
• UDI-Device Identifier: 08717648233104
• UDI-Public: (01)08717648233104(17)270728(10)4080741
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2025

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 Model Number: 1804250-28
• Device Catalogue Number: 1804250-28
• Device Lot Number: 4080741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2024
• 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; Hospitalization
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White