MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number	1550250-23
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Angina (1710); Myocardial Infarction (1969); Thrombosis (2100)
Date of Event	07/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.The reported patient effects of angina, myocardial infarction and thrombosis are listed in the xience sierra everolimus eluting coronary stent systems, instructions for use, as known patient effects of coronary stenting procedures.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure as it is likely the device interacted with the difficult anatomy during inflation of the balloon causing the reported difficulty to deploy.Additionally, anti-coagulant medication was suspended due to an unrelated medical condition which likely caused the patient effects of angina and myocardial infarction.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that on (b)(6) 2018, dual antiplatelet therapy (dapt) was started on a patient who presented with acute myocardial infarction (mi).A 2.5x23mm xience sierra stent was deployed to treat the mi.Intravascular ultrasound (ivus) showed insufficient dilatation of the stent due to heavy calcification.At an unknown date, dapt was discontinued due to melena and administration of clopidogrel sulfate was started.At an unknown date, all anti-coagulant medication was discontinued for colorectal cancer surgery.On (b)(6) 2018, the patient presented with chest pain, which was diagnosed as myocardial infarction.In-stent subacute coronary thrombosis was confirmed by angiography.An intraaortic balloon pump (iabp) was inserted.Thrombus was aspirated with an aspiration catheter and long-period dilatation was performed with a non-abbott balloon catheter.Following thrombus aspiration, administration of aspirin and prasugrel hydrochloride was resumed.The patient was admitted to the intensive care unit and the iabp is and will be inserted to secure blood flow for two days or so.The patient is in the hospital doing fine and is scheduled to be discharged within two weeks.The patient is recovering.No additional information was provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7733512
• Report Number: 2024168-2018-05881
• Device Sequence Number: 19468427
• Product Code: NIQ
• UDI-Device Identifier: 08717648227110
• UDI-Public: 08717648227110
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/30/2018

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 Catalogue Number: 1550250-23
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 07/30/2018
• 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; Disability