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

Catalog Number	1550400-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intimal Dissection (1333); Dyspnea (1816); Ischemia (1942); Stenosis (2263)
Date of Event	12/19/2018
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 stent remains in patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.
Event or Problem Description
It was reported that on (b)(6) 2018, the patient underwent a coronary procedure, treating a target lesion in the proximal left anterior descending (lad).A 4.0 x 38 mm xience sierra stent was implanted, and a proximal edge dissection was noted.No treatment was reported.On (b)(6) 2019, the patient reported experiencing dyspnea on exertion.Pharmocologic stress testing was performed and revealed a moderate to severe perfusion defect with extensive ischemia.On (b)(6) 2019, the patient was re-hospitalized, with dyspnea on exertion.Restenosis was noted at the proximal stent edge and a revascularization procedure was performed.No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001.There was no reported device malfunction and the product was not returned as it remains implanted.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 intimal dissection, dyspnea, ischemia and stenosis 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
Patient id: (b)(6).

• 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: 8848971
• Report Number: 2024168-2019-10501
• Device Sequence Number: 2267672
• Product Code: NIQ
• UDI-Device Identifier: 08717648227547
• UDI-Public: 08717648227547
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2019

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: 07/29/2019
• Device Catalogue Number: 1550400-38
• Device Lot Number: 8071942
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 09/03/2019
• 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: 50 YR
• Patient Weight: 91