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

Catalog Number 1070350-28

Device Problems Unintended System Motion (1430); Patient-Device Incompatibility (2682)

Patient Problem Vascular Dissection (3160)

Event Date 09/22/2021

Event Type  Injury  

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 identified no other similar incidents from this lot.The reported patient effect of dissection is listed in the xience everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.It is possible that during inflation interaction with the mildly tortuous and 90% stenosed anatomy resulted in the reported difficulties; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.The patient effect of dissection and treatment appears to be related to the operational context of the procedure as the physician implanted a same size xience xpedition over the dislodged xience xpedition stent to fully appose it to the vessel wall, treat the dissection and cover the rest of the untreated part of the target lesion.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

Event Description

It was reported that the procedure was to treat a mildly tortuous left anterior descending artery that was 90% stenosed.After advancement of a 3.5x28mm xience xpedition stent to the lesion, during inflation for deployment, the stent shifted only partially covering the target lesion and not fully apposed to the vessel wall.Additionally, the vessel was noted as dissected.The physician then implanted a same size xience xpedition over the previous xience xpedition stent to fully appose it to the vessel wall, treat the dissection and cover the rest of the untreated part of the target lesion.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.

• Brand Name: XIENCE XPEDITION 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: 12665409
• MDR Text Key: 277394414
• Report Number: 2024168-2021-09409
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2023
• Device Catalogue Number: 1070350-28
• Device Lot Number: 0061741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention