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

Catalog Number	1804300-15
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: device code 2017 clarifier - use after damage.H6: device code 2017 clarifier - failure to follow steps / instructions.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 moderately tortuous mid left anterior descending artery (lad) lesion.When pulling the 3.0x15mm xience skypoint stent delivery system (sds) out of the hoop; resistance was met.The yellow portion of stylet was held; however a 90-degree angle was noted at the end of the stylet.Resistance was noted when removing the stylet.The sds was inserted into the body and when attempting to deploy the stent, it was not visible under fluoroscopy.The stent was located inside the yellow stylet on the prep table.The sds was removed without issue.Another skypoint was used to complete the procedure.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported stent dislodgement and deformation due to compressive stress was confirmed.The reported difficult to remove (hoop/tray) could not be tested as the sds was not retuned for evaluation.The reported difficult to remove (mandrel/stylet) could not be tested due to the condition of the returned device.The electronic lot history record (elhr) and exception reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no similar incidents from this lot.It should be noted that the xience skypoint, everolimus eluting coronary stent system (eecss), electronic instructions for use (eifu), states to carefully remove the system from the package and inspect for bends, kinks, and other damage.Verify that the stent does not extend beyond the radiopaque balloon markers.Do not use if any defects are noted.It is unknown if the ifu deviation directly caused or contributed to the reported event.The investigation determined that the reported difficulties appear to be related to the operational context of the procedure, as it is likely that inadvertent mishandling during removal of the device from the protective coil, stylet and protective sheath contributed to the reported difficult to remove (hoop/tray and mandrel/stylet), causing the reported deformation due to compressive stress in addition to the observed material deformation, deformation due to compressive stress (sheath), torn sheath and bent stylet, ultimately causing the reported stent dislodgement inside the protective sheath.There is no indication of a product quality issue with respect to manufacture, design, or labeling of the device.

• 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: 18874111
• Report Number: 2024168-2024-03085
• Device Sequence Number: 12742566
• Product Code: NIQ
• UDI-Device Identifier: 08717648233234
• UDI-Public: (01)08717648233234(17)260426(10)3050841
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2024

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: 04/26/2026
• Device Catalogue Number: 1804300-15
• Device Lot Number: 3050841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 03/29/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2023
• 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