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

Model Number 1550300-18

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

Patient Problems Cardiac Enzyme Elevation (1838); Prolapse (2475)

Event Date 08/12/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.It should be noted that the reported patient effect of prolapse is listed in the xience sierra, everolimus eluting coronary stent system instructions for use as a known patient effect of coronary stenting 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 of the device.

Event Description

Patient id: (b)(6).It was reported that on (b)(6) 2020, a percutaneous coronary intervention (pci) was performed on the proximal circumflex (cx) coronary artery, 80% stenosed lesion.A 3.0x18mm xience sierra stent was implanted in the cx and post-dilatation performed.Post-procedure there was timi flow iii and 0% residual stenosis.Following, plaque shift occurred.As treatment, additional balloon angioplasty was performed.Elevated cardiac enzymes were also noted post-procedure.There was no diagnosed myocardial infarction and there was no additional 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: 10494750
• MDR Text Key: 205696079
• Report Number: 2024168-2020-07396
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227264
• UDI-Public: 08717648227264
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1550300-18
• Device Catalogue Number: 1550300-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 62