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

Catalog Number	1804400-38
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: medical device problem code 2017 clarifier- incorrect prep.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 the 4.0x38mm rx xience skypoint stent delivery system was prepared for use prior to removing the protective sheath.Slight resistance was noted when removing the protective sheath.The stent was noted to be elongated at the distal end.There was no clinically significant delay in the procedure and no patient involvement.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported stent dislodgement and material deformation were confirmed.The reported difficult to remove could not be tested due to the condition of the returned device.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.It was reported the 4.0x38mm rx xience skypoint stent delivery system was prepared for use prior to removing the protective sheath.It should be noted that the xience skypoint, everolimus eluting coronary stent system (eecss), electronic instructions for use states: prior to preparation of the device, remove the product mandrel and protective stent sheath by grasping the catheter just proximal to the stent (at the proximal balloon bond site), and with the other hand, grasp the stent protector and gently move distally.It is unknown if the ifu deviation directly caused or contributed to the reported event.A conclusive cause for the reported difficulties could not be determined; however, factors that could contribute to material deformation include.In this case, it is possible that inadvertent mishandling during sheath/stylet removal and/or unpackaging of the device, as slight resistance was noted during removal of the protective sheath, may have contributed to the reported difficult to remove, causing the reported material deformation (stent damage), ultimately causing the reported stent dislodgement; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.

• 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: 19105226
• Report Number: 2024168-2024-04674
• Device Sequence Number: 7705316
• Product Code: NIQ
• UDI-Device Identifier: 08717648233524
• UDI-Public: (01)08717648233524(17)261018(10)3102541
• 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): 05/17/2024

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 Catalogue Number: 1804400-38
• Device Lot Number: 3102541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/29/2024
• Supplement Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2023
• 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