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

Catalog Number	1550225-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Respiratory Distress (2045); Thrombosis (2100)
Date of Event	10/18/2018
Type of Reportable Event	Serious Injury
Additional 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 cardiac arrest, hypotension, respiratory distress, and thrombosis are listed in the xience sierra everolimus eluting coronary stent systems electronic instructions for use as known patient effects of coronary stenting procedures.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 other xience sierra device is being filed under a separate medwatch mfr number.
Event or Problem Description
It was reported that the procedure was to treat a circumflex artery.Two xience sierra stents (2.25x38 and 3.25x23) were successfully implanted at the lesion.There were no device issues and the stents were well-apposed to the vessel wall.While finishing the case, the patient stated they didn't feel right and there was a drop in blood pressure.A thrombus was observed in both stents and a thrombectomy was performed.The patient then stopped breathing and experienced cardiopulmonary arrest.Cardiopulmonary resuscitation was performed, the patient was intubated, medications provided, and a balloon pump (iabp) was placed to stabilize the patient.The patient was taken to critical care for observation.The event required prolonged hospitalization.There was no adverse patient sequela reported.No additional information was provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8035373
• Report Number: 2024168-2018-08437
• Device Sequence Number: 16469383
• Product Code: NIQ
• UDI-Device Identifier: 08717648227066
• UDI-Public: 08717648227066
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/02/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/20/2019
• Device Catalogue Number: 1550225-38
• Device Lot Number: 8050941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 11/02/2018
• 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; Life Threatening; Required Intervention
• Patient Age: 58 YR