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

Model Number 1550400-15

Device Problem Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/10/2022

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a saphenous vein graft (svg) in the distal right coronary artery (rca).The 4.0x15mm xience sierra stent was deployed at 14 atmospheres without issue.A dilatation balloon catheter (bdc) was advanced to post dilate the stent when it was noted the sierra stent had migrated from the distal to the mid rca (approximately 10-15mm).The bdc post dilated the sierra to ensure it would not migrate any further.A non-abbott stent was then implanted at the target lesion.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported stent migration; however, the subsequent foreign body in patient and unexpected medical intervention (additional therapy/non-surgical treatment) appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE SIERRA 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: 13541074
• MDR Text Key: 285667883
• Report Number: 2024168-2022-01595
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227493
• UDI-Public: 08717648227493
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2023
• Device Model Number: 1550400-15
• Device Catalogue Number: 1550400-15
• Device Lot Number: 1030241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• 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
• Patient Outcome(s): Required Intervention