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

Catalog Number 1500250-38

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

Patient Problems Intimal Dissection (1333); Cardiac Enzyme Elevation (1838); Thrombosis (2100); Prolapse (2475)

Event Date 05/15/2019

Event Type  Injury  

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.It should be noted that the reported patient effects of intimal dissection, thrombosis and prolapse are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as known patient effects of coronary procedures.A conclusive cause for the reported patient effect(s), 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 xience sierra stent mentioned is being filed under a separate medwatch report number.

Event Description

Patient id: (b)(6).It was reported that on (b)(6) 2019, the patient presented with a mid-left anterior descending (lad) 90% stenosed lesion, and a mid-right coronary artery (rca) 70% stenosed lesion.Following pre-dilatation, a 2.5x38mm xience sierra stent (1500250-38, 9030141) was implanted in the mid lad.Post-stent placement, an intra-stent plaque, thrombus, and an edge dissection was observed.Additional post-dilatation performed.The end result was 0% residual stenosis with timi flow iii.Reportedly, there was no device malfunction.A 3.5x23mm xience sierra stent (1500350-23, 9030441) was implanted in the mid rca.Post stent implantation, an intra-stent plaque protrusion and an edge dissection were observed.Additional post-dilatation was performed and a 3.5x8mm xience sierra stent (1500350-08, 8112041) stent was implanted.Reportedly, there was no device malfunction the end results were 0% residual stenosis with timi flow iii.That same day post-procedure, elevated cardiac enzymes were observed and significantly elevated enzymes were observed (b)(6) 2019.Reportedly, the elevation was not serious, there was no associated serious injury, there was no device malfunction, and no treatment provided.The event resolved without sequela.No additional information was provided regarding this issue.

• Brand Name: XIENCE SIERRA 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: 10359454
• MDR Text Key: 203297988
• Report Number: 2024168-2020-06449
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/03/2020

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: 03/12/2022
• Device Catalogue Number: 1500250-38
• Device Lot Number: 9030141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 81