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

Catalog Number	1804400-18
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the electronic lot history record and similar incident query for this product was not performed because the lot number was not reported and the product was not returned for analysis.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.B3, b6, d6a: dates estimated.E1 - facility name: (b)(6) hospital.Attachment: article title - proximal optimization technique with an ultra-short balloon as a bailout strategy for stent protrusion into the left main trunkna.
Event or Problem Description
It was reported in a case study that was conducted for a bailout strategy on stent protrusion, that a 4.0 x 18mm xience skypoint stent delivery system (sds) was deployed to treat the ostial left anterior descending artery for cross-over stenting.However, intravascular ultrasound (ivus) was performed and a slight stent protrusion from the lad into the left main trunk (lmt) was observed, with jailed stent struts at the ostial left circumflex (lcx) artery and malapposed stent struts at the lmt.Therefore, a proximal optimization technique (pot) was performed using a non-abbott balloon to dilate the jailed struts at the ostium of the lcx.And expanding the malapposed struts at the lmt to prevent a dissection.Ivus was performed again after pot was completed, and confirmed a well-enlarged stent cell at the ostial lcx and adequate stent apposition.A one year follow up was performed and confirmed the stent was patent.Optical coherence tomography (oct) was performed with a dragonfly opstar imaging catheter, and confirmed remarkable expansion the stent struts without any restenosis.Residual jailed struts on the proximal site of the bifurcation was present, and material with high intensity but no attenuation was adhered to the jailed strut no additional treatment was needed.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: 18093779
• Report Number: 2024168-2023-12418
• Device Sequence Number: 6877107
• Product Code: NIQ
• UDI-Device Identifier: 08717648233487
• UDI-Public: 08717648233487
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1804400-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 64 YR
• Patient Sex: Male