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

Catalog Number UNK RX XPEDITION

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

Patient Problem Death (1802)

Event Date 01/01/2015

Event Type  Death  

Manufacturer Narrative

Outcomes to adverse event, date of event, implant date: estimated dates.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.The device was not returned for evaluation.A review of the lot history record could not be conducted because the part and lot number was not provided.The reported patient effect of death is listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary procedures.A conclusive cause for the reported death and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional patient effects referenced are being filed under a separate medwatch report number.

Event Description

It was reported in a research article that xience xpedition stents may be related to death, in-stent restenosis, target lesion failure, hospitalization and repeat revascularization.Specific patient and procedural information is not known.Additional.

• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11396003
• MDR Text Key: 234198565
• Report Number: 2024168-2021-01573
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK RX XPEDITION
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 60 YR