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

Catalog Number	1550225-18
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	02/21/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 effect of death is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as known patient effect 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.
Event or Problem Description
It was reported that the procedure was to treat a moderately tortuous, mildly calcified mid circumflex artery.Pre-dilatation was performed with a 2.25x15mm mini trek balloon dilatation catheter.Then a 2.25x18mm xience sierra stent was implanted at the lesion.There were no device issues noted with the xience sierra.Afterwards, the physician attempted to use a dragonfly catheter to perform an optical coherence tomography procedure, but a good quality pull back could not be attained.The dragonfly catheter was then retrieved and the procedure was successfully completed via unknown methods.It was confirmed that the patient was compliant with dual antiplatelet drug therapy.The next day, the patient died; however, the cause of death is unknown.An autopsy was not performed.The physician mentioned that the patient had experienced st- elevation myocardial infarction two weeks before the procedure.Per the physician, the device did not cause or contribute to the patient's death in any way.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: 8401311
• Report Number: 2024168-2019-01790
• Device Sequence Number: 2326594
• Product Code: NIQ
• UDI-Device Identifier: 08717648227028
• UDI-Public: 08717648227028
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2019

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: 09/05/2019
• Device Catalogue Number: 1550225-18
• Device Lot Number: 8082441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: DRAGONFLY
• Outcome Attributed to Adverse Event: Death
• Patient Age: 73 YR