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

Catalog Number 1500250-33

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

Patient Problem Vascular Dissection (3160)

Event Date 04/01/2024

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.The lot history record and exception reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no similar incidents from this lot.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.The reported patient effect of dissection is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.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 moderately calcified, mildly tortuous left anterior descending artery that is 90% stenosed.The patient presented with severe angina and the vessel was pre-dilatated with a 2.0x8mm semi-compliant balloon.A 2.5x33mm xience sierra stent was deployed at 13 atmospheres and fluoroscopy after stenting revealed an edge dissection.The dissection was covered with another xience sierra stent.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

• 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: 19054012
• MDR Text Key: 339550220
• Report Number: 2024168-2024-04371
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648218330
• UDI-Public: (01)08717648218330(17)260924(10)3092841
• Combination Product (y/n): Y
• Reporter Country Code: IN
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1500250-33
• Device Lot Number: 3092841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/25/2023
• 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: 53 YR
• Patient Sex: Male