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

Model Number	1550350-38
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Angina (1710); Myocardial Infarction (1969); Thrombosis (2100); Respiratory Failure (2484)
Date of Event	01/13/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The 3.0x38mm xience sierra stent, referenced is being filed under a separate medwatch report number.The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) 2020, a percutaneous coronary intervention (pci) was performed on the proximal right coronary artery (rca), 70% stenosed lesion.Pre-dilatation and atherectomy was performed on the rca.Following rotablator use, a proximal rca dissection occurred.Reportedly, a 3.5x15mm xience sierra stent was implanted at the rca ostium due to this dissection.There was no underexpansion confirmed or reported and no device malfunction.As planned, 3.0x38mm and 3.5x38mm xience sierra stents were implanted in the proximal rca.Post-dilatation was performed using a non-compliant balloon.The diameter stenosis was reduced to 25% with timi flow iii.On (b)(6) 2020, the patient was hospitalized for severe substernal chest pain.Medications including nitroglycerin had been provided.Elevated troponin and a st elevated myocardial infarction (stemi) was diagnosed.Per imaging, the ostial-proximal rca was patent, however, the proximal rca with the 3.0x38mm and 3.5x38mm xience sierra stents, to the distal rca, was occluded with 100% thrombus.Reportedly, both the 3.0x38mm and 3.5x38mm xience sierra stents were underexpanded.High pressure balloon angioplasty was performed, resolving the occlusion.On (b)(6) 2020, the patient passed away due to respiratory failure, pneumonia, and the stemi, related to this hospitalization.No additional information was provided regarding this issue.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.It should be noted that the reported patient effects of angina, death, respiratory failure, myocardial infarction and thrombosis are listed in the xience sierra, everolimus eluting coronary stent system instructions for use as known patient effects of coronary stenting procedures.The investigation determined the reported patient-device incompatibility/difficult to deploy (wall apposition) and the subsequent treatments appear to be related to the operational context of the procedure; however, a conclusive cause for the reported patient effect(s), 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.

• 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: 9714114
• Report Number: 2024168-2020-01500
• Device Sequence Number: 11676051
• Product Code: NIQ
• UDI-Device Identifier: 08717648227462
• UDI-Public: 08717648227462
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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: 10/22/2020
• Device Model Number: 1550350-38
• Device Catalogue Number: 1550350-38
• Device Lot Number: 9101641
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2 XIENCE SIERRA STENTS.; 6 FRENCH GUIDE CATHETER.; 2 XIENCE SIERRA STENTS; 6 FRENCH GUIDE CATHETER
• Outcome Attributed to Adverse Event: Death
• Patient Age: 82 YR
• Patient Weight: 93