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

Catalog Number	1804250-23
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Perforation of Vessels (2135); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
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 that the procedure was to treat the left anterior descending (lad) coronary artery.Intravascular ultrasound (ivus) was performed and then the 2.5x23 mm xience skypoint stent was deployed without issue.A non-abbott balloon was used for post dilatation.A perforation was noted in the lad and diagonal arteries.Two additional non-abbott stents were placed in the lad and a coil was placed in the diagonal.The patient was transferred to a higher level of care and was then discharged when they recovered.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 query of the complaint handling system for the reported / original / relabeled lot was not performed as no device issue or patient effect related to the device was reported.The investigation was unable to determine any issue with the device as no patient effects or device malfunction/failure mode were reported.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: health effect - clinical code 2135 removed; 4582 added.Health effect - impact codes 4641, 4607 removed; 2199 added.Medical device problem code 2993 removed; 3189 added.
Event or Problem Description
It was reported that the procedure was to treat the left anterior descending (lad) coronary artery.Intravascular ultrasound (ivus) was performed and then the 2.5x23 mm xience skypoint stent was deployed without issue.A non-abbott balloon was used for post dilatation.A perforation was noted in the lad and diagonal arteries.Two additional non-abbott stents were placed in the lad and a coil was placed in the diagonal.The patient was transferred to a higher level of care and was then discharged when they recovered.Subsequent to the initially filed report, it was reported that in the physician's opinion, the xience skypoint stent did not cause or contribute to the perforation.Based on the additional information this complaint would not have been reportable; however, since the initial report has already been filed, this complaint must remain reportable.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: 18370161
• Report Number: 2024168-2023-14320
• Device Sequence Number: 20775150
• Product Code: NIQ
• UDI-Device Identifier: 08717648233098
• UDI-Public: 08717648233098
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/21/2026
• Device Catalogue Number: 1804250-23
• Device Lot Number: 3063041
• 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
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 02/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2023
• 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: NC EMERGE BALLOON.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female