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

Catalog Number	1125300-23
Health Effect - Clinical Codes	Angina (1710); Thrombosis (2100); Prolapse (2475)
Date of Event	11/11/2016
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.(b)(4).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 and related record review, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.Angina and thrombosis are listed in the xience alpine everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.It should be noted that the xience alpine everolimus eluting coronary stent system electronic instructions for use states: the xience alpine stent system is indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions.In addition, the xience alpine stent system is indicated for treating de novo chronic total coronary occlusions.Based on the information reviewed, 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 an unspecified date, the patient underwent a coronary stenting procedure with implantation of an unspecified stent in the circumflex/obtuse marginal artery.On (b)(6) 2016, the patient was re-hospitalized and in-stent restenosis was noted in the unspecified stent.The 3.0 x 23 mm xience alpine stent was implanted inside the previously implanted stent and post dilatation was performed using a 4.0 nc dilatation catheter.On (b)(6) 2016, the patient was re-hospitalized with angina and the previously implanted xience alpine stent was noted to be occluded with thrombus.Optical coherence tomography (oct) was performed and it was noted that there appeared to be a plaque rupture with thrombus.Pre-dilatation was performed using a 2.0 x 20 mm dilatation catheter.A 3.5 x 25 mm non-abbott stent was implanted.Post dilatation was performed using a 3.75 x 12 mm nc balloon.It was reported that the patient was compliant with dual antiplatelet therapy of effient and aspirin.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: 6111557
• Report Number: 2024168-2016-08059
• Device Sequence Number: 10836322
• Product Code: NIQ
• UDI-Device Identifier: 08717648199363
• UDI-Public: (01)08717648199363
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2016

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: 1125300-23
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2016
• Initial Report FDA Received Date: 11/17/2016
• 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: Hospitalization; Required Intervention