MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1070250-48

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

Patient Problem Vascular Dissection (3160)

Event Date 12/14/2021

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a heavily calcified, mildly tortuous, 90% stenosed lesion in the left anterior descending (lad) artery.The lesion was pre-dilatated with a 3x12mm traveler balloon dilatation catheter (bdc) and a 2.5x48mm xience xpedition drug eluting stent (des) was implanted at the target lesion.Post-dilatation was completed with a 2.5x12mm nc traveler bdc, after which a distal end dissection was noted.A 2.5x12mm xience xpedition was implanted to cover the dissection and successfully complete the procedure.There was no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.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 dissection is listed in the xience xpedition 48, everolimus eluting coronary stent system (eecss), instructions for use (ifu) as a known patient effect of coronary stenting procedures.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.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.The xience xpedition 48 is currently not commercially available in the us; however, it is similar to a device sold in the us.

• Brand Name: XIENCE XPEDITION 48 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: 13114624
• MDR Text Key: 282978664
• Report Number: 2024168-2021-12264
• Device Sequence Number: 1
• Product Code: NIQ
• 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: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2024
• Device Catalogue Number: 1070250-48
• Device Lot Number: 1032341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2021
• 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
• Treatment: 2.5 X 12MM NC TRAVELER; 2.5 X 12MM NC TRAVELLER; 3.0 X 12 TRAVELER BALOON; 3.0 X 12 TRAVELLER BALOON
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male