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

Catalog Number	1804325-28
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Device Damaged by Another Device (2915); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
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.A cine was received and reviewed by an abbott vascular clinical specialist and concluded the probable cause of the incident is that the nc trek balloon had difficulty navigating a turn in the artery and caused or worsened the xience skypoint stent¿s malapposition in the process of entering the deployed stent.Malapposition of a stent is not a malfunction of a device, but rather an accepted part of stent implantation that is then checked and addressed through oct visualization and post-deployment dilatation.The investigation determined the reported difficulties related to device damaged by another, material deformation and treatment appear to be related to circumstances of the procedure.The investigation was unable to determine a conclusive cause for the reported wall apposition.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional device referenced in b5 is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a short lesion in the proximal left anterior descending (plad) artery.The versaturn guide wire was advanced.Pre-dilatation was performed using a 2.5x12 trek rx balloon dilatation catheter (bdc) followed by the first optical coherence tomography (oct) run in the lad.The 3.25x28mmmm xience skypoint stent was then implanted.The 3.25x15mm nc trek neo bdc was used for post dilatation, however, there was resistance felt at the proximal edge of the xience skypoint stent, due to the bdc not being able to bend the curve of the vessel and after pushing slightly was able to advance to the distal portion of the stent and dilatation was performed without issues.Another oct run was performed to check the placement of the stent and upon evaluation of the oct image, it was noted that there was significant malapposition of the stent and an absence of stent struts on the opposing wall which was confirmed in the longitudinal mode display demonstrating that 2 of the proximal stent struts were prolapsed on one another.The opposing wall of the stent had lifted from the wall causing a >300 micron malapposition.The physician then decided to inflate a 3.5 x12 trek rx balloon proximally in order to ensure appropriate apposition without issues.Another oct run was performed to evaluate the result of the 3.5 balloon inflation.Results demonstrated a complete resolution to the malapposition.The versaturn guide wire was removed and the case was completed without incidence.Patient was discharged without complication.There was no adverse patient effect and although there was small delay in the procedure, there was no patient harm.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: 18369650
• Report Number: 2024168-2023-14303
• Device Sequence Number: 12657523
• Product Code: NIQ
• UDI-Device Identifier: 08717648233340
• UDI-Public: 08717648233340
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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
• Report Date (Section B): 12/20/2023

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: 03/22/2026
• Device Catalogue Number: 1804325-28
• Device Lot Number: 3032941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OPTICAL COHERENCE TOMOGRAPHY (OCT); VERSATURN GUIDE WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown