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

Model Number 1804300-33

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Vessels (2135)

Event Date 08/02/2021

Event Type  Injury  

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 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
• Type of Device: 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 ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12370849
• MDR Text Key: 268250696
• Report Number: 2024168-2021-07548
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233272
• UDI-Public: (01)08717648233272(17)230323(10)1031541
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 3.5X12MM NC TREK BALLOON
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR