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

Model Number	1804225-28
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Angina (1710); Non specific EKG/ECG Changes (1817)
Date of Event	10/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a 90% stenosed lesion in the proximal right coronary artery (prca).The 2.25x28mm xience skypoint drug eluting stent (des) was advanced to the target lesion without issue but the indeflator did not hold pressure and contrast was observed via imaging on the first inflation attempt at 1 atmosphere (atm) indicating a balloon rupture.The contrast leaked and entered the artery, and the patient had a brief episode of chest pain and st changes.The stent remained on the balloon after the rupture and the device was removed without issue.The angina and st changes were treated with morphine and nitrile glycerin, which resolved quickly, after which a non-abbott stent was used to successfully complete the procedure.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and functional inspection was performed on the returned device.The reported material rupture was confirmed.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.The reported patient effect of angina is listed in the xience skypoint, everolimus eluting coronary stent system (eecss), electronic instructions for use (eifu) as a known patient effect of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported material rupture.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.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: 12816749
• Report Number: 2024168-2021-10380
• Device Sequence Number: 4757627
• Product Code: NIQ
• UDI-Device Identifier: 08717648233029
• UDI-Public: 08717648233029
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 11/15/2021

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: 06/22/2023
• Device Model Number: 1804225-28
• Device Catalogue Number: 1804225-28
• Device Lot Number: 1061041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2021
• 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: MEDTRONIC STENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown