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

Catalog Number	1009539-28
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	04/17/2015
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.A partial udi is being reported because the lot number was not provided.On (b)(6) 2014 the patient was hospitalized due to inflammation of the lungs and heat stroke which were both treated with medication.On (b)(6) 2014 the heat stroke symptoms were improved.On (b)(6) 2014 the inflammation of the lungs was improved.On (b)(6) 2014 the patient was hospitalized to treat arteriosclerotic obliteration.Reportedly it was not restenosis and the location was unknown.On (b)(6) 2014 the patient was noted to have anemia and was treated with blood infusion.The patient had experienced anemia also in the past.On (b)(6) 2015 a family member of the patient noticed that there was something odd about the patient and on (b)(6) 2015 the patient was taken by ambulance to the hospital due to loss of consciousness.On (b)(6) 2015 infective endocarditis was noted.Echocardiography was performed and a vegetation-like image was identified on the anterior cusp of the mitral valve.On (b)(6) 2015 disseminated intravascular coagulation (dis) developed.On (b)(6) 2015 the level of consciousness of the patient was decreased.On (b)(6) 2015 the patient expired due to septicemia.Per the physician the patient cause of death was sepsis caused by bacteria and was not related to either the unknown xience stent or the 2.5x28mm xience v stent.No additional information was provided.Dapt: aspirin from prior to the procedure ((b)(6) 2010) to (b)(6) 2015 (during the period, stopped medication from (b)(6) 2012).Clopidogrel from (b)(6) 2010 to (b)(6) 2015 (during the period, stopped medication from (b)(6) 2012).The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.Based on the case information, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.Death and intimal dissection are listed in the xience v everolimus eluting coronary stent systems instructions for use as known patient effect(s) of coronary stenting procedures.Based on the information reviewed, 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 the index procedure date was (b)(6) 2010.The patient was admitted to treat restenosis and an unknown xience stent was successfully implanted in the mid left anterior descending artery.In the same procedure, another lesion in the obtuse marginal branch with 100% stenosis was also treated.On (b)(6) 2010, and (b)(6) 2011, follow-up coronary angiography (cag) was performed and it was confirmed that there were no angina symptoms and that the patient was compliant with dual antiplatelet drug therapy (dapt).On (b)(6) 2011 a 2.5x28mm xience v stent was implanted to treat a lesion in the posterior lateral branch with 75% stenosis and a distal edge dissection occurred.On (b)(6) 2012 a follow-up cag was performed and it was confirmed that the patient was compliant with dapt.On (b)(6) 2012 dapt was temporarily stopped due to a biopsy for stomach cancer where the patient was treated via surgery and medication for the stomach cancer.On (b)(6) 2012 dapt was restarted as the patients condition became stable after the surgery.On (b)(6) 2013 follow-up cag was performed and it was confirmed that there were no angina symptoms and the patient was compliant with dapt.On (b)(6) 2014, the patient presented with inflammation of the lungs, the patient was hospitalized and medication was given to treat the symptoms.On (b)(6) 2014 the patients condition was improved.On (b)(6) 2014 follow-up cag was performed and it was confirmed that there were no angina symptoms and that the patient was compliant with dapt.).

• 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: 5877094
• Report Number: 2024168-2016-05424
• Device Sequence Number: 1425858
• Product Code: NIQ
• UDI-Device Identifier: 08717648063879
• UDI-Public: (01)08717648063879
• 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: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/15/2016

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 Catalogue Number: 1009539-28
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2016
• Initial Report FDA Received Date: 08/15/2016
• 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: Other
• Patient Age: 71 YR