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

Catalog Number	1804300-12
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the left anterior descending (lad) coronary artery with mild calcification and mild tortuosity.The 3.0x12mm xience skypoint sent delivery system (sds) was advanced through the lesion; however, could not be implanted due to resistance from an unspecified previously implanted stent; therefore, the device was being removed when the stent became dislodged from the balloon inside the patient's body.Another non-abbott stent was used in an attempted to cover the lesion where the xience skypoint was intended to be implanted; however, it was deployed at the left main since could not cross due to the dislodged stent.The patient was sent to surgery and was hospitalized.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 should be noted that the xience skypoint everolimus eluting coronary stent system instruction for use (ifu) states: applying excessive force to the delivery system can potentially result in loss of or damage to the stent and/or delivery system components.In this case, it appears the ifu deviation related to force may have contributed to the reported stent dislodgement; however, it is likely the resistance with the difficult anatomy felt prior to dislodgment caused the reported stent dislodgement.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: device code 2017 clarifier: against resistance.
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 should be noted that the xience skypoint everolimus eluting coronary stent system instruction for use states: applying excessive force to the delivery system can potentially result in loss of or damage to the stent and/or delivery system components.In this case, it appears the instruction for use (ifu) deviation related to force may have contributed to the reported stent dislodgement; however, it is likely the resistance with the difficult anatomy felt prior to dislodgment caused the reported stent dislodgement.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.B5 - describe event or problem: updated.
Event or Problem Description
Subsequent to the initially filed report, additional information was provided which stated that a coronary artery bypass grafting (cabg) was performed but the patient expired since a do-not-resuscitate order (dnr) was requested.The physician stated the xience skypoint stent did not cause or contribute to the patient death.No additional information was provided.

• 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: 17977512
• Report Number: 2024168-2023-11628
• Device Sequence Number: 11654664
• Product Code: NIQ
• UDI-Device Identifier: 08717648233227
• UDI-Public: 08717648233227
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 12/04/2023

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 Expiration Date: 09/05/2024
• Device Catalogue Number: 1804300-12
• Device Lot Number: 2083041
• 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: 09/25/2023
• Supplement Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male