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

Catalog Number 1804400-18

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2020

Event Type  malfunction  

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 review of the complaint history identified no other incidents from this lot.The investigation was unable to determine a conclusive cause for the reported deflation issues; however, factors that may contribute to deflation issues include, but are not limited to, manufacturing damage, contrast mixing, bent/kinked shaft while inside the anatomy affecting the deflation lumen and/or stretched outer member (om) thereby reducing the deflation lumen.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat a mildly calcified, tortuous and 90% stenosed lesion in the distal right coronary artery.Following pre-dilatation with a non-abbott balloon, a 4.0x18mm xience skypoint stent was advanced to the lesion and the stent deployed and implanted at 14 atmospheres for 10 seconds; however, deflation seemed slow.The delivery system was successfully removed, without reported issue.There was no adverse patient effect or a clinically significant delay.No additional information was provided.

• Brand Name: XIENCE SKYPOINT EVEROLIMUS ELUTING CORONARY STENT 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 ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11013148
• MDR Text Key: 222069461
• Report Number: 2024168-2020-10532
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648233487
• UDI-Public: 08717648233487
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2023
• Device Catalogue Number: 1804400-18
• Device Lot Number: 0090241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1