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

Catalog Number 1804225-15

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Material Too Soft/Flexible (4007)

Patient Problem Insufficient Information (4580)

Event Date 01/20/2021

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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the 99% stenosed, heavily tortuous, and heavily calcified anatomy resulting in the reported failure to advance and the reported difficult to remove.The reported material too soft/flexible (support of the sds was inferior to the non-abbott sds) is an opinion of the physician and not a quality issue with respect to manufacture, design or labeling with the product.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 performed to treat a 99% stenosed, heavily tortuous, and heavily calcified concentric lesion in the posterior lateral artery.A 2.25x15mm xience skypoint stent delivery system (sds) was being advanced with a guide catheter extension; however, the sds failed to cross due to resistance with the anatomy.The sds was removed but resistance with the anatomy was noted.The procedure was successfully completed with a non-abbott stent.The physician commented that the deliverability/support of the xience skypoint was inferior to the non-abbott sds.There were no adverse patient effects and no clinically significant delay in the procedure.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 ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11616633
• MDR Text Key: 245083290
• Report Number: 2024168-2021-02770
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648232992
• UDI-Public: 08717648232992
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2023
• Device Catalogue Number: 1804225-15
• Device Lot Number: 0081941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 75