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

Catalog Number	1550300-12
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Intimal Dissection (1333); Angina (1710); Occlusion (1984)
Date of Event	11/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical devices: 6 french diagnostic catheter, dragonfly optis optical coherence tomography catheter, aspirin, prasugrel.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.The reported patient effects of intimal dissection, angina and occlusion are listed in the xience sierra, everolimus eluting coronary stent system instructions for us as known patient effects of coronary stenting procedures.The investigation determined the reported difficulty to deploy (wall apposition) and subsequent treatments appear to be related to circumstances of the procedure.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 this was a coronary procedure, performed on (b)(6) 2018, to treat a lesion in the ramus artery.Optical coherence tomography was performed during the procedure and a 3.0 x 12 mm xience sierra stent was implanted.Additional post-dilatation was performed, as it was noted that the stent was under expanded.On (b)(6) 2018, the patient presented to the emergency room with chest pain.Coronary angiography was performed and noted occlusion in the mid ramus and distal closure due to dissection.Two additional xience stents were implanted and the event resolved.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: 8122638
• Report Number: 2024168-2018-09189
• Device Sequence Number: 11157865
• Product Code: NIQ
• UDI-Device Identifier: 08717648227240
• UDI-Public: 08717648227240
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: health professional,study
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/30/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/26/2019
• Device Catalogue Number: 1550300-12
• Device Lot Number: 8082041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/01/2018
• 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: 80 YR
• Patient Weight: 78