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

Catalog Number 1070300-48

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

Patient Problem Intimal Dissection (1333)

Event Date 09/03/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.The reported patient effect of dissection is listed in the xience xpedition 48 everolimus eluting coronary stent system instructions for use as a known patient effect of coronary stenting procedures.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.However, the treatment appears 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.The xience xpedition 48 is currently not commercially available in the u.S.; however, it is similar to a device sold in the u.S.

Event Description

It was reported that the procedure was performed to treat an 80% stenosed, moderately tortuous, and moderately calcified lesion in the left circumflex artery.The patient presented with sever angina.Following pre-dilatation, a 3.0x48mm xience xpedition stent was deployed at 16 atmospheres.Fluoroscopy post-stenting showed an edge dissection at the proximal end of the stent.The dissection was successfully treated with an unspecified xience xpedition stent.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

• 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: 10576858
• MDR Text Key: 208298830
• Report Number: 2024168-2020-07965
• 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: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2022
• Device Catalogue Number: 1070300-48
• Device Lot Number: 9082241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2020
• Initial Date FDA Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR