MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1074300-08

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

Patient Problems Death (1802); Ischemia (1942); Prolapse (2475)

Event Date 03/15/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant products: stent: resolute integrity 2.5x30mm, 3.0x38mm; xience xpedition 3.0x38mm.The device was not returned for evaluation.However, ischemia and death are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.There is no indication of a product quality issue with respect to manufacture, design or labeling.The xience xpedition 3.0x38mm is filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat lesions located in the left main and proximal left anterior descending coronary arteries on (b)(6) 2016.After ablation was performed with a non-abbott device, a perforation occurred.Non-abbott stents were implanted to treat the perforation.Then, two xience xpedition (3.0 x 38 mm and 3.0 x 8 mm) stents were implanted.After implantation of the xience xpedition stents, blood flow was decreased and the patient's condition changed for the worse.In spite of intra-aortic balloon pump (iabp) and percutaneous cardio pulmonary support (pcps) followed by coronary artery bypass graft (cabg), on (b)(6) 2016, the patient expired.The cause of death was reported as heart failure due to the decreased blood flow caused by plaque, however it could not be confirmed when the plaque shift occurred; after implant of one or both stents.No additional information can be provided.

• Brand Name: XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6271746
• MDR Text Key: 65564559
• Report Number: 2024168-2017-00633
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648162312
• UDI-Public: (01)08717648162312
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1074300-08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death