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

Catalog Number	1804350-38
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: device code 2017 - failure to follow steps / instructions, sheath removal.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 performed to treat a lesion in the right coronary artery.The patient was being urgently treated for a st-segment elevation myocardial infarction (stemi); therefore, the 3.5x38mm xience skypoint stent delivery system (sds) was opened and put straight into the patient¿s body without prepping.The sds was advanced and deployed; however, once the sds was removed and angiography was performed it was noted that there was no stent at the deployment site.The vessel looked as if it had just been ballooned.Post-procedure the stent was found on the stylet and partially in the protective sheath.It was reported that the tech was removing the protective sheath and stylet but, pinched too hard and the stent came off with it.The procedure was successfully completed with the deployment of a new 3.5x38mm xience skypoint stent.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.It was reported that the tech was removing the protective sheath and stylet but, pinched too hard and the stent came off with it.It should be noted that the xience skypoint everolimus eluting coronary stent system instruction for use (ifu) states: remove the product mandrel and protective 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 remove distally.It was also reported that the stent delivery system was used without prepping prior to use.In this case, it is likely the reported user error related to pinching during sheath stylet removal caused the reported stent dislodgement during sheath removal.The device was used after the stent dislodgement without prepping with contrast against instructions for use.There is no indication of a product quality issue with respect to manufacture, design or labeling.D9, h3.The device was initially reported as returning for analysis, but the device was not returned.

• 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: 17757647
• Report Number: 2024168-2023-10062
• Device Sequence Number: 17808511
• Product Code: NIQ
• UDI-Device Identifier: 08717648233449
• UDI-Public: 08717648233449
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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): 11/08/2023

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: 11/13/2024
• Device Catalogue Number: 1804350-38
• Device Lot Number: 2111541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/24/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2022
• 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: 64 YR
• Patient Sex: Female
• Patient Weight: 64 KG