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

Catalog Number	1125250-18
Health Effect - Clinical Codes	Intimal Dissection (1333); Angina (1710); Myocardial Infarction (1969); Thrombosis (2100)
Date of Event	04/14/2018
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.The reported patient effects of dissection, angina, myocardial infarction and thrombosis are listed in the xience alpine 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.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 manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was performed on (b)(6) 2018 to treat a lesion in the proximal left anterior descending (lad) coronary artery.A 2.5 x 18 mm xience alpine stent was implanted successfully.The stent implant was fully apposed.There were no adverse patient effects reported.The patient was discharged with no complications.The patient was compliant with dual antiplatelet drug therapy after the procedure.On (b)(6) 2018, the patient was re-hospitalized with unstable chest pain with non- st-elevation myocardial infarction (stemi) and was treated with medication.However, it was noted that the patient had a lump on her neck.The patient was discharged from the hospital.On (b)(6) 2018, the patient returned with chest pain and it was noted that the lad had closed off.Angiography confirmed a distal edge dissection which caused in-stent thrombosis.Angioplasty was performed with an nc trek balloon catheter and a 2.75 x 23 xience alpine stent was used to treat the in-stent thrombosis successfully.Post dilatation was performed with a 3.0 x 20 mm nc trek balloon catheter.The patient was discharged with a good outcome.No additional information was provided.

• Brand Name: XIENCE ALPINE 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: 7453005
• Report Number: 2024168-2018-02991
• Device Sequence Number: 19175691
• Product Code: NIQ
• UDI-Device Identifier: 08717648199172
• UDI-Public: 08717648199172
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1125250-18
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 04/23/2018
• 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
• Patient Age: 74 YR
• Patient Weight: 79