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

Catalog Number	1550250-28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Respiratory Distress (2045); Heart Failure (2206)
Date of Event	09/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.A review of the electronic lot history record (elhr) revealed no non-conformities associated with this lot.The reported patient effects of cardio-respiratory arrest (respiratory distress) and heart failure (cardiac failure) are listed in the xience 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 the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified left circumflex artery that was 90% stenosed.On (b)(6) 2018, the patient presented with ischemia without any symptoms.Therefore, a 2.5 x 28 mm xience sierra stent was implanted in the lesion.It was confirmed that the patient was compliant with dual antiplatelet drug therapy after the procedure.Then on (b)(6) 2018, the patient was urgently re-hospitalized for respiratory distress and heart failure.Therefore, furosemide, nicardipine and potassium aspartate were administered intravenously.Additionally, oxygen therapy (bilevel positive airway pressure (bipap)) was performed.On (b)(6) 2018, spironolactone and furosemide were administered orally.On (b)(6) 2018, intravenous injection of potassium aspartate was stopped.On (b)(6) 2018, oxygen therapy was stopped.On (b)(6) 2018, the patient recovered and was discharged from the hospital.It remains unknown whether the stent is patent or not.It was reported that the device did not cause or contribute to the adverse patient effects.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: 7952346
• Report Number: 2024168-2018-07812
• Device Sequence Number: 1380139
• Product Code: NIQ
• UDI-Device Identifier: 08717648227127
• UDI-Public: 08717648227127
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/10/2018

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: 04/29/2019
• Device Catalogue Number: 1550250-28
• Device Lot Number: 8041641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 10/10/2018
• 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; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 49