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

Model Number	1804225-12
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a lesion in the distal right coronary artery (drca) with heavy calcification.The 2.25x12mm xience skypoint stent delivery system (sds) was advanced but initially stated as failed to deploy.The balloon was deflated and it was noted that there was no stent and the stent was found in the protective sheath.However, the patient suffered a dissection with some contrast flowing outside the artery.It was contained.The patient will be brought back and make another attempt to complete the procedure.There was a clinically significant delay in the procedure.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.H6: medical device problem code 2017 - failure to follow steps / instructions.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the distal right coronary artery (drca) with heavy calcification.The 2.25x12mm xience skypoint stent delivery system (sds) was advanced but initially stated as failed to deploy.The balloon was deflated and it was noted that there was no stent and the stent was found in the protective sheath.However, the patient suffered a dissection with some contrast flowing outside the artery.It was contained.The patient will be brought back and make another attempt to complete the procedure.There was a clinically significant delay in the procedure.Subsequent to filing the initial report, update to event or problem: the dissection was not treated but was contained.
Additional Manufacturer Narrative
A visual, and dimensional inspection was performed on the returned device.The reported stent dislodgement was confirmed.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 other complaints.The reported patient effect of dissection is listed in the xience skypoint, everolimus eluting coronary stent system (eecss), electronic instructions for use (eifu) as a known patient effect of coronary stenting procedures.It was reported that the xience skypoint was inserted into the body and once the balloon was inflated/deflated, the stent was found in the protective sheath.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.A conclusive cause for the reported stent dislodgement could not be determined; however, stent dislodgement may be attributed to several factors including, but not limited to, improper or inadequate crimping at the time of manufacture, incorrect sheath sizing, positive pressure during preparation, forced sheath removal, handling of the stent during preparation, interaction with the anatomy, or interaction with accessory devices.In this case, it is possible that inadvertent mishandling during sheath/stylet removal and/or preparation of the device may have contributed to the reported stent dislodgement; however, this cannot be confirmed.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 19533846
• Report Number: 2024168-2024-07142
• Device Sequence Number: 7606802
• Product Code: NIQ
• UDI-Device Identifier: 08717648232985
• UDI-Public: (01)08717648232985(17)261106(10)3111541
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 06/27/2024

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 Model Number: 1804225-12
• Device Catalogue Number: 1804225-12
• Device Lot Number: 3111541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 83 KG