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

Catalog Number	1009539-12
Health Effect - Clinical Codes	Ischemia (1942); Stenosis (2263)
Date of Event	05/09/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.Ischemia and stenosis are listed in the xience v everolimus eluting coronary stent systems instructions for use (ifu) as known patient effects of coronary stenting procedures.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 and there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
Event or Problem Description
It was reported that on (b)(6) 2011, a 2.5x12mm xience v stent was successfully implanted in the distal left anterior descending (lad) coronary artery lesion.On (b)(6) 2013, the patient was admitted to the hospital due to silent ischemia and restenosis of the distal lad stent.On (b)(6) 2013, percutaneous intervention was performed as treatment.The event resolved without sequela and on (b)(6) 2013, the patient was discharged from the hospital.There was no additional information provided.

• 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: 6042438
• Report Number: 2024168-2016-07096
• Device Sequence Number: 19187424
• Product Code: NIQ
• UDI-Device Identifier: 08717648063794
• UDI-Public: (01)08717648063794(17)120914(10)0083141
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P070015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/19/2016

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: 09/14/2012
• Device Catalogue Number: 1009539-12
• Device Lot Number: 0083141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2016
• Initial Report FDA Received Date: 10/19/2016
• 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: ASPIRIN, CLOPIDOGREL
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 64