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

Model Number	1550300-28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Myocardial Infarction (1969); Tachycardia (2095); Ventricular Fibrillation (2130); Stenosis (2263); Prolapse (2475)
Date of Event	06/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.It should be noted that the reported patient effect(s) of myocardial infarction, ventricular arrhythmias, stenosis, prolapse and angina are listed in the xience sierra everolimus eluting coronary stent system instructions for use as a known patient effect(s) of coronary procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) 2019, the patient presented with silent ischemia and severe calcification within the proximal circumflex (cx) coronary artery, 75% stenosed lesion.Atherectomy was performed and a 2.75x33mm (1550275-33, 8080241) and 3.0x28mm (1550300-28, 8080941) xience sierra stents were implanted in the cx with acceptable results.Post-implantation, intra-stent plaque protrusion was observed with the 3.0x28mm xience sierra stent.Additional balloon dilatation was performed.On (b)(6) 2020, the patient was admitted to the hospital with chest pain, elevated troponin, and a non-st elevated myocardial inflation (nstemi) was diagnosed.Medication had been taken prior and a heparin drip was initiated.The patient went into ventricular tachycardia/ventricular fibrillation arrest.Cardiopulmonary resuscitation was performed and cardioversion shocks were provided two times.On (b)(6) 2020, the proximal cx, 3.0x28mm xience sierra stent, was observed with 90% occlusion, in-stent restenosis within the proximal 5mm of the stent.As treatment, another stent was implanted.The event resolved.There was no device malfunction.No additional information was provided regarding this issue.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10537644
• Report Number: 2024168-2020-07733
• Device Sequence Number: 14443195
• Product Code: NIQ
• UDI-Device Identifier: 08717648227288
• UDI-Public: 08717648227288
• Combination Product (Y/N): Y
• 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): 09/15/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/22/2019
• Device Model Number: 1550300-28
• Device Catalogue Number: 1550300-28
• Device Lot Number: 8080941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 09/15/2020
• 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; Life Threatening; Required Intervention; Disability
• Patient Age: 60 YR
• Patient Weight: 113