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

Catalog Number 1550225-15

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

Patient Problem Perforation (2001)

Event Date 09/09/2019

Event Type  Injury  

Manufacturer Narrative

There was no reported device malfunction and the product was not returned as the stent remains in the anatomy.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 xience sierra everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effect of coronary stenting procedures.Based on the case information and related record review, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined and the treatment appears to be related to the circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

Event Description

It was reported that during a coronary procedure, a 2.5 x 33 mm xience sierra stent and a 2.25 x 15 mm xience sierra stent were implanted in the left anterior descending (lad) artery.Post dilatation was performed at the 2.25 x 15 mm xience sierra stent and a perforation occurred.The 2.8 x 19 mm graftmaster stent was advanced; however, the graftmaster was unable to cross through the 2.25 x 15 mm xience sierra stent.Several attempts were made; however, the graftmaster was unable to cross.The device was removed, and it was noted that the delivery system shaft was kinked.Additional balloon dilatation was performed to treat the perforation, and the perforation was sealed.Post procedure, the patient was in stable condition.No additional information was provided.

• Brand Name: XIENCE SIERRA
• 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: 9131829
• MDR Text Key: 160450062
• Report Number: 2024168-2019-12188
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227011
• UDI-Public: 08717648227011
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110019
• 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: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2020
• Device Catalogue Number: 1550225-15
• Device Lot Number: 9041041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 68