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

Catalog Number	1804300-28
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
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.
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified, moderately tortuous mid left anterior descending artery.The 3.0x28mm xience skypoint stent delivery system was deployed; however, not fully opposed to the vessel wall and had become bent.Therefore, an unspecified balloon catheter was used to remove the stent.A new unspecified stent was used and implanted to successfully complete the procedure.There was no adverse patient sequela and no clinically significant delay in the procedure.
Additional Manufacturer Narrative
The device was not returned for evaluation.Production record 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 similar complaints from this lot.The investigation determined the reported difficulties and subsequent unexpected medical intervention appear to be related to circumstances of the procedure, as it is likely the device interacted with the mildly calcified, moderately tortuous lesion during deployment, causing the reported patient-device incompatibility (wall apposition) in addition to the reported material deformation.An unspecified balloon catheter was used to remove the stent.A new unspecified stent was used and implanted to successfully complete the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Correction c9 - #1 event reappeared after reintro: updated from "none selected" to "doesn't apply".

• 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: 19335233
• Report Number: 2024168-2024-05977
• Device Sequence Number: 3009750
• Product Code: NIQ
• UDI-Device Identifier: 08717648233265
• UDI-Public: (01)08717648233265(17)270122(10)4020141
• 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
• Device Explanted 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): 06/11/2024

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 Catalogue Number: 1804300-28
• Device Lot Number: 4020141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2024
• 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
• Patient Sex: Unknown