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 Codes	Angina (1710); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Thrombosis (2100); Respiratory Failure (2484)
Date of Event	12/04/2018
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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of death, hypotension, angina, cardio-respiratory arrest, cardiac failure and thrombosis are listed in the xience sierra, everolimus eluting coronary stent system (eecss), 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 three xience sierra stents referenced are filed under separate medwatch report numbers.
Event or Problem Description
It was reported that the procedure was to treat a mildly tortuous and mildly calcified obtuse marginal branch, the diagonal branch and the left anterior descending artery.A 2.25 x 12 mm xience sierra stent was implanted in the obtuse marginal branch, a 2.25 x 18 mm xience sierra stent was implanted in the diagonal branch and a 2.5 x 38 mm xience sierra stent was implanted in the left anterior descending (lad) artery without any issues.However, the patient complained of discomfort and then became hypotensive and experienced cardiac arrest.Therefore, cardiopulmonary resuscitation (cpr) was started and the patient was intubated.It was noted that there was no flow in the vessels that were stented due to thrombus.Therefore, balloon angioplasty was performed in the proximal circumflex, diagonal and lad arteries.Aspiration was performed to remove the thrombus and a 2.5 x 38 mm xience sierra stent was implanted in the distal lad.Cpr continued; however, the patient expired that same day on (b)(6) 2018.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: 8197815
• Report Number: 2024168-2018-10046
• Device Sequence Number: 19414373
• Product Code: NIQ
• UDI-Device Identifier: 08717648227028
• UDI-Public: 08717648227028
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 12/26/2018

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: 09/05/2019
• Device Catalogue Number: 1550225-18
• Device Lot Number: 8082241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 12/26/2018
• 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: Death
• Patient Age: 81 YR
• Patient Weight: 65