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

Catalog Number 1550400-23

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Angina (1710); Thrombosis (2100)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this event.The reported patient effects of thrombosis and angina are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported difficulty to deploy (wall apposition).A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The 4.0x38mm xience sierra is filed under a separate medwatch report number.

Event Description

It was reported that on (b)(6) 2018, the patient presented with angina.The procedure was to treat a lesion located in a moderately tortuous, moderately calcified concentric mid to distal right coronary artery (rca) a 4.0x23mm xience sierra stent and a 4.0x38mm xience sierra stent were deployed in an overlapped manner.Timi flow changed from 2 to 3.Intravascular ultrasound (ivus) was confirmed to successfully complete the procedure.It was confirmed that the patient was compliant with dual antiplatelet drug therapy after the procedure.On (b)(6) 2018, the patient was re-hospitalized due to chest pain.In-stent thrombus was confirmed via angiography.The stent was recoiled.Balloon angioplasty was performed with a 4.0x12mm unspecified balloon.On (b)(6) 2018, the patient was discharged from the hospital.No additional information was provided.

• Brand Name: XIENCE SIERRA 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): CLONMEL, IRELAND REG# 9616693; 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: 8086925
• MDR Text Key: 127851886
• Report Number: 2024168-2018-08933
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227516
• UDI-Public: 08717648227516
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2021
• Device Catalogue Number: 1550400-23
• Device Lot Number: 8031241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 81 YR