MAUDE Adverse Event Report: ABBOTT VASCULAR INC. XIENCE SKYPOINT¿; CORONARY DRUG-ELUTING STENT

Model Number	1804275-28
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Difficult to Advance (2920)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)
Date of Event	08/20/2024
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 that the right coronary artery (rca) was closed and the left anterior descending (lad) was heavily calcified.A 2.5x12mm unspecified balloon was used; however did not produce results therefore, shockwave was performed and was able to move the balloon more distal.A 2.75x38mm xience skypoint was advanced and it was noted patient was on impella.Ejection fraction was wasn't good, patient was very sick.The stent was deployed; however, distal portion of stent was not fully apposed due to the heavy calcium.A 2.5x15 non-compliant balloon was used to try to open up the stent where it did not expand, but was unsuccessful.A 3.0 unspecified balloon was used with a higher pressure, around 16 atmospheres (atms), then went with 3.5 non-compliant balloon and inflated to 16 atms again and stent expanded.Perforation was observed and pressure started dropping, which epinephrine and levophed drips were given.Patient still on impella and took another balloon for perforation, did tamponade, held pressure with balloon for a couple minutes.The unspecified guide catheter with unspecified guide wire slipped out as the guide catheter tilted upwards and the vessel was more downward trajectory.It was noted there was not great guide support.Rewiring was attempted for three minutes; however, unsuccessful as no wire could cross the xience stent.Patient went into cardiac arrest and cardiopulmonary resuscitation was performed but patient expired.Per the physician, the xience skypoint did not cause or contribute to patient's death.Clinically significant delay was noted.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the production records and the corrective and preventive actions (capa) database was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation determined the reported difficulties and treatments appear to be related to the operational context of the procedure; however, a cause for the subsequent treatments patient effects cannot be determined.It was reported that the stent delivery system (sds) interacted with the patient¿s heavily calcified lesion, resulting in difficulty crossing the lesion.Additionally, it was reported that the lesion calcification also contributed to the stent failing to fully appose to the wall (patient-device incompatibility).Per the physician, the xience skypoint did not cause or contribute to patient's death.The reported patient effect of low blood pressure / hypotension, perforation, death, and cardiac arrest are listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: XIENCE SKYPOINT¿
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 20192933
• Report Number: 2024168-2024-10690
• Device Sequence Number: 7517729
• Product Code: NIQ
• UDI-Device Identifier: 08717648233203
• UDI-Public: (01)08717648233203(17)270304(10)4030841
• 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
• Device Implanted Year: 2024
• 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): 10/10/2024

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 Model Number: 1804275-28
• Device Catalogue Number: 1804275-38
• Device Lot Number: 4030841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2024
• 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: 2.5X15 NON-COMPLIANT BALLOON; 3.5 NON-COMPLIANT BALLOON
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female