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

Model Number	1804300-33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	08/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no reported device malfunction and the product was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of perforation is listed in the everolimus eluting coronary stent system (eecss) xience skypoint wh, fda, instruction for use as a known patient effect.A conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined.Additionally, the treatment appears to be related to operational context of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a highly calcified proximal left anterior descending artery.A 3x33mm xience skypoint stent was advanced and implanted at the lesion without issue.When performing standard post-dilatation with a 3.5x12mm nc trek balloon it was inflated once at an unspecified atmosphere and it was noted that a perforation occurred.A rx graftmaster stent was used to treat the perforation and sealed it successfully.There was no adverse patient sequela and no clinically significant delay.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
• MDR Report Key: 12370849
• Report Number: 2024168-2021-07548
• Device Sequence Number: 11845515
• Product Code: NIQ
• UDI-Device Identifier: 08717648233272
• UDI-Public: (01)08717648233272(17)230323(10)1031541
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/23/2023
• Device Model Number: 1804300-33
• Device Catalogue Number: 1804300-33
• Device Lot Number: 1031541
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.5X12MM NC TREK BALLOON
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR