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

Catalog Number	1125400-23
Health Effect - Clinical Codes	Myocardial Infarction (1969); Thrombus (2101)
Date of Event	11/16/2017
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.The reported patient effect(s) of thrombosis is listed in the xience alpine everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect(s), 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.The xience alpine device is currently not commercially available in the us; however, it is similar to a device sold in the us.
Event or Problem Description
It was reported that the patient presented emergently with a non-st-elevation myocardial infarction where they were taken to the cath lab and pre-dilated, and a xience alpine 4 x 23 mm stent was deployed in the mid-right coronary artery.During this initial procedure, the patient was given angiomax.After the stent was implanted there was no post-dilatation or imaging performed.Thirty minutes post-procedure, the patient coded and cardiopulmonary resuscitation was successfully administered.The patient then returned to the cath lab where it was discovered via angiography that the stent had thrombosed.The patient was aspirated and post-dilatation was performed with a high pressure, non-compliant balloon.The patient was given heparin and integrilin and was doing well post-procedure.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: 7073387
• Report Number: 2024168-2017-09301
• Device Sequence Number: 1275926
• Product Code: NIQ
• UDI-Device Identifier: 08717648199639
• UDI-Public: 08717648199639
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/30/2017

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: 01/03/2019
• Device Catalogue Number: 1125400-23
• Device Lot Number: 5121641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2017
• Initial Report FDA Received Date: 11/30/2017
• 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: Required Intervention