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

Model Number	1009540-15
Health Effect - Clinical Codes	Angina (1710); Stenosis (2263); Test Result (2695)
Date of Event	03/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 of angina and stenosis are listed in xience v everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effect(s) of coronary stenting procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.However, the treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The 3.5x12mm xience v stent referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that on (b)(6) 2013, 3.5x12mm and 2.75x15mm xience v stents were implanted in the left main (lm) coronary artery and proximal circumflex (cx) coronary artery lesions.On (b)(6) 2017, the patient was hospitalized for unstable angina.Troponin was negative.Stress test was positive.Per imaging, there was restenosis in both xience v stents in the left main (lm) and circumflex (cx) arteries.Dual antiplatelet therapy (dapt) medications were changed and another percutaneous intervention was performed in the proximal right coronary artery (rca) de novo lesion.The event resolved without sequela.On (b)(6) 2017, the patient was hospitalized for angina.Dapt medication was provided.Non-abbott stents were placed in the rca.On (b)(6) 2017, the patient was hospitalized for angina.Cardiovascular medication was provided and percutaneous intervention was performed in the proximal cx, placing a xience stent in the restenosed 3.5x12mm and 2.75x15mm xience v stents.The patient was discharged from the hospital in stable condition.There was no additional information provided regarding this issue.

• Brand Name: XIENCE V 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: 6703157
• Report Number: 2024168-2017-05781
• Device Sequence Number: 652608
• Product Code: NIQ
• UDI-Device Identifier: 08717648063930
• UDI-Public: (01)08717648063930(17)141018(10)2100741
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P070015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/11/2017

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: 10/18/2014
• Device Model Number: 1009540-15
• Device Catalogue Number: 1009540-15
• Device Lot Number: 2100741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2017
• Initial Report FDA Received Date: 07/11/2017
• 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: 75 YR
• Patient Weight: 71