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

Model Number	1550400-18
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Angina (1710); Thrombosis (2100)
Date of Event	01/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The stent remains in the patient.A review of the lot history record identified no manufacturing nonconformities that would have contributed to this event.A review of the complaint history did not indicate a lot-specific quality issue.The reported patient effects of angina and thrombosis 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 stent break; however, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that on (b)(6) 2019 the 4.0x18 mm xience sierra stent was implanted in the mildly tortuous left circumflex coronary artery without incident.The stent was well apposed and intact, but optical coherence tomography was not performed.The patient was discharged from the hospital and was compliant with the dual anti-platelet therapy.On (b)(6) 2020 the patient had chest pain and was re-admitted to the hospital.Angiogram found in-stent thrombus in the 4.0x18 xience sierra.The physician reported that the thrombus was likely caused by the xience sierra stent having a stent fracture, but a fracture was not visualized.There was also a hematoma in the vessel.The patient did not have a myocardial infarction.A second 4.0x18 mm xience sierra was implanted inside the first sierra.The patient was discharged from the hospital.No additional information was provided.

• Brand Name: XIENCE SIERRA
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9624269
• Report Number: 2024168-2020-00871
• Device Sequence Number: 16289997
• Product Code: NIQ
• UDI-Device Identifier: 08717648227509
• UDI-Public: 08717648227509
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/23/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/27/2020
• Device Model Number: 1550400-18
• Device Catalogue Number: 1550400-18
• Device Lot Number: 9062141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 01/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 95