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

Catalog Number	1550250-38
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Angina (1710); Myocardial Infarction (1969); Thrombosis (2100)
Date of Event	09/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 as it remains implanted.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 other incidents from this lot.The reported patient effects of angina, myocardial infarction and thrombosis are listed in the xience sierra everolimus eluting coronary stent systems instructions for use (ifu) as known patient effects of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported difficulty to deploy (wall apposition).Based on the case information and related record review, 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 design, manufacture or labeling of the device.The other implanted xience sierra stent is filed under a separate medwatch report.
Event or Problem Description
It was reported that on (b)(6) 2019 patient presented with an acute myocardial infarction.Two xience sierra stents were implanted in the mid to proximal left anterior descending (lad) coronary artery.On (b)(6) 2019, the patient presented with unstable angina and a myocardial infarction was diagnosed.Angiography was performed and confirmed thrombosis in both stents.Thrombectomy was performed with good results.Intravascular ultrasound (ivus) was performed and sub-optimal stent deployment was noted and treated with additional balloon dilatation.It was confirmed that patient had been compliant with dual anti-platelet therapy post implant of the two xience stents.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: 9169019
• Report Number: 2024168-2019-12437
• Device Sequence Number: 2830344
• Product Code: NIQ
• UDI-Device Identifier: 08717648227141
• UDI-Public: 08717648227141
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/14/2019
• Device Catalogue Number: 1550250-38
• Device Lot Number: 8100841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 10/08/2019
• 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: OTHER IMPLANTED SIERRA STENT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability