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

Catalog Number	1550250-33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Death (1802); Ischemia (1942); Thrombosis (2100)
Date of Event	03/10/2019
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.Concomitant medical products: stent: xience sierra: 2.5x33, 3.0x38; aspirin, brilinta.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 angina, death, ischemia, and thrombosis are listed in the sierra, everolimus eluting coronary stent systems 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 manufacture, design or labeling.The 2.5x33mm ans 3.0x38mm xience sierra stents referenced are filed under separate medwatch reports.
Event or Problem Description
It was reported that the patient was admitted on (b)(6) 2019, with st elevation myocardial infarction (stemi).Coronary intervention was performed, and two xience sierra stents (2.5x33mm, 3.0x38mm) were implanted in the proximal left anterior descending (lad) artery, in an overlapping fashion.A 2.5x33mm xience sierra stent was implanted in the first obtuse marginal (om1) artery.Post dilatation was performed per facility protocol, at both lesions.The activated clotting time (act) was noted to be 225 on the first measurement, and 290 on the second.Aspirin and brilinta were administered.Two days post procedure, the patient had complaints of worsening chest pain.Coronary angiography was performed and noted thrombus in the lad and om1.Balloon angioplasty was performed.Although poor flow was noted, the vessels were opened.The act was noted to be 400.An integrilin drip was started.On (b)(6) 2019, the patient had complaints of jaw pain and died.Cause of death was related to weakened condition from the admitting stemi, stent thrombosis, and pulmonary embolus.Per physician, the pulmonary embolus was not related to the implanted stent.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: 8562489
• Report Number: 2024168-2019-03392
• Device Sequence Number: 13837163
• Product Code: NIQ
• UDI-Device Identifier: 08717648227134
• UDI-Public: 08717648227134
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/29/2019

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: 09/26/2019
• Device Catalogue Number: 1550250-33
• Device Lot Number: 8091941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 04/29/2019
• 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: 58 YR