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

Catalog Number	1804250-38
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Shock (2072); Foreign Body In Patient (2687); Vascular Dissection (3160)
Date of Event	04/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 xience skypoint drug eluted stent (des) 2.50 x 38 rx was to be used in the mid left anterior descending (mlad) lesion.However, resistance was felt and the stent failed to cross.The stent dislodged in the radial artery and has yet to be removed.A dissection occurred with subsequent poor flow.The patient was sent to the operating room (or) and was placed on impella and is in intensive care unit (icu).The procedure completed with using a non-abbott device.There were no adverse patient sequelae and no reported clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the initial report, the following information was provided: it was reported the xience skypoint drug eluted stent (des) 2.50 x 38 rx was to be used in the mid left anterior descending (mlad) lesion.However, resistance was felt and the stent failed to cross.The stent dislodged in the radial recurrent artery (rra) and has yet to be removed.A dissection occurred with subsequent poor flow.The dissection was treated with an unknown stent.The patient was sent to the operating room (or) and was placed on impella due to going into cardiogenic shock and is in intensive care unit (icu).The procedure completed with using a non-abbott device.There were no adverse patient sequelae and no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.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 did not indicate a lot specific quality issue.A conclusive cause for the reported difficulties could not be determined; however, factors that could contribute to failure to advance include, but are not limited to, patient anatomical morphology, patient disease state, pre-dilatation strategy, device placement technique, interaction with previously placed stents or accessory devices.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.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent unexpected medical intervention, foreign body in patient and surgical intervention appear to be related to the operational context of the procedure.In this case, it is possible the device may have interacted with the mildly calcified, mildly tortuous lesion during advancement, causing the reported failure to advance, ultimately causing the reported stent dislodgement; however, without the device to examine, this cannot be confirmed.The reported patient effects of shock and dissection are listed in the xience skypoint, everolimus eluting coronary stent system (eecss), electronic instructions for use (ifu) as known patient effects of coronary stenting procedures.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: 19222927
• Report Number: 2024168-2024-05337
• Device Sequence Number: 6923527
• Product Code: NIQ
• UDI-Device Identifier: 08717648233128
• UDI-Public: (01)08717648233128(17)260227(10)3030641
• 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): 05/17/2024

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 Expiration Date: 02/27/2026
• Device Catalogue Number: 1804250-38
• Device Lot Number: 3030641
• 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: 04/08/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2023
• 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: Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male