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

Catalog Number	1550325-38
Health Effect - Clinical Codes	Angina (1710); Cardiac Enzyme Elevation (1838); Thrombosis (2100)
Date of Event	06/13/2018
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 angina, and thrombosis 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 effect 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 on (b)(6) 2018, the patient presented with chest pain.Thrombotic occlusion was confirmed in the heavily calcified proximal right coronary artery (rca).A 3.25 x 38mm xience sierra stent was deployed at 12 atmospheres (atm).Post-dilatation was performed with a 3.5 x 15mm balloon at 14 atm.Flow was improved to timi 3, and chest pain was improved.No stent malapposition was confirmed by intravascular ultrasound (ivus).In the morning of (b)(6) 2018, paroxysms of chest pain occurred, and creatine kinase (ck) value was increased.In-stent thrombosis was confirmed by angiography.Thrombus aspiration was performed followed by angioplasty with a 3.5 x 12mm balloon; however, thrombus remained.A 3.5x20mm perfusion balloon was inflated for 10 minutes and the thrombus vanished.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: 7639875
• Report Number: 2024168-2018-05056
• Device Sequence Number: 11356894
• Product Code: NIQ
• UDI-Device Identifier: 08717648227387
• UDI-Public: 08717648227387
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2018

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: 03/09/2021
• Device Catalogue Number: 1550325-38
• Device Lot Number: 8022741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 06/26/2018
• 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: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 70