MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number	1550250-28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Weakness (2145); Stenosis (2263); Prolapse (2475)
Date of Event	01/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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 dyspnea, prolapse and stenosis 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 manufacture, design or labeling of the device.
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) 2019, a 2.5 x 28 mm xience sierra stent was implanted in the 1st obtuse marginal artery.After stent implantation, optical coherence tomography noted insignificant plaque shift and additional post dilatation was performed.Post procedure, the plaque shift resolved.On (b)(6) 2019, the patient had complaints of shortness of breath and weakness.Percutaneous coronary intervention was performed and in-stent restenosis was noted.Angioplasty was performed, using a high pressure sculpting balloon.The event resolved the same day.No additional information was provided.

• Brand Name: XIENCE SIERRA
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8972560
• Report Number: 2024168-2019-11564
• Device Sequence Number: 16199815
• Product Code: NIQ
• UDI-Device Identifier: 08717648227127
• UDI-Public: 08717648227127
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/06/2019

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: 09/23/2019
• Device Catalogue Number: 1550250-28
• Device Lot Number: 8091441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 09/06/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 101