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

Model Number	1804400-38
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.(b)(4).
Event or Problem Description
It was reported that the procedure was to treat a mildly calcified, mildly tortuous left anterior descending artery.The 4.0x38mm xience skypoint stent delivery system (sds) failed to cross the lesion due to anatomy.The sds was removed and attempted to be re-inserted with a non-abbott telescope extension catheter; however, the sds became stuck inside the guide extension and the stent implant slid off the balloon; however, remained on the delivery system.The sds was removed along with the stent and extension catheter as one unit.Another smaller size xience skypoint was used to successfully complete the procedure.There was no adverse patient effects reported and no clinically significant delay in the procedure.No additional information wasp provided.
Additional Manufacturer Narrative
A visual, dimensional, and functional investigation was performed on the returned device.The reported failure to advance could not be tested as it was based on the operational context of the procedure.The reported difficult to remove, difficult to advance, and stent dislodgement could not be confirmed.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 of the reported lot did not indicate a lot specific quality issue.It was reported that the sds was inserted into the anatomy, retracted, and then re-inserted.It should be noted that the xience skypoint instructions for use (ifu) states; an unexpanded stent may be retracted into the guiding catheter one time only.An unexpanded stent should not be reintroduced into the artery once it has been pulled back into the guiding catheter.Subsequent movement in and out through the distal end of the guiding catheter should not be performed, as the stent may be damaged or dislodged during retraction back into the guiding catheter.It is unknown if the ifu deviation directly caused or contributed to the reported event.The investigation determined the reported failure to advance appears to be related to the operational context of the procedure.Furthermore, the investigation was unable to determine a conclusive cause for the reported difficult to remove, difficult to advance, and stent dislodgement.In this case, it is likely that the sds interacted with the mildly calcified and mildly tortuous anatomy during advancement, as resistance was noted, resulting in the reported failure to advance.Factors that could contribute to difficult to advance include, but are not limited to, interaction with accessory devices, patient¿s disease state, and/or patient¿s anatomical morphology.Factors that could contribute to difficult to remove include, but are not limited to, interaction with accessory devices, patient¿s disease state, and/or patient¿s anatomical morphology.Factors that could contribute to a stent dislodgement include, but are not limited to, mishandling during preparation, interaction with accessory devices, and/or patient¿s disease state.In this case, it is possible that the sds interacted with the guide catheter extension during advancement, as resistance was noted, contributing to the reported difficult to advance.Further interaction with the guide catheter extension during retraction, as resistance was again noted, possibly contributed to the reported difficult to remove and subsequent stent dislodgement; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 13538665
• Report Number: 2024168-2022-01587
• Device Sequence Number: 5148285
• Product Code: NIQ
• UDI-Device Identifier: 08717648233524
• UDI-Public: 08717648233524
• Combination Product (Y/N): Y
• 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): 04/12/2022

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: 09/19/2023
• Device Model Number: 1804400-38
• Device Catalogue Number: 1804400-38
• Device Lot Number: 1091541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TELESCOPE EXTENSION CATH 6 F
• Patient Sex: Male