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

Model Number	1804300-48
Medical Device Problem Codes	Leak/Splash (1354); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
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
It was reported that the procedure was to treat a lesion in the right coronary artery (rca) with heavy calcification and mild tortuosity.The 3x48mm xience skypoint stent delivery system (sds) was attempted to be implanted at the target lesion; however, the stent was not able to be completely deployed.Therefore, the sds was removed and blood and air was noted to be leaking from the proximal shaft.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection and functional analysis were performed on the returned device.The reported shaft leak and activation failure were not confirmed.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 reported information and the observations from the returned analysis, a definitive cause for the reported issue could not be determined.The device was returned, the stent was returned fully deployed and the delivery system was inflated without issue.The reported activation failure and shaft leak could not be confirmed.It should be noted that the inner member of the delivery system was collapsed which may have caused difficulty with inflation; however, this cannot be confirmed as it could not be replicated during return device functional testing.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.

• 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: 20281177
• Report Number: 2024168-2024-11197
• Device Sequence Number: 7563978
• Product Code: NIQ
• UDI-Device Identifier: 08717648231285
• UDI-Public: (01)08717648231285(17)270507(10)4051341
• 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,Followup
• Report Date (Section B): 11/11/2024

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: 1804300-48
• Device Catalogue Number: 1804300-48
• Device Lot Number: 4051341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2024
• Supplement Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2024
• 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
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 48 KG
• Patient Race: Asian