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

Catalog Number	1125350-38
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	10/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Post procedure, it was determined that the bleeding was coming from the patients ear and there was no brain bleed.The patient was placed on a balloon pump post procedure to help stabilize the blood pressure.No additional information was provided.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.Based on the case information and related record review, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined; however, the reported treatments appear to be related to circumstances of the procedure.The reported patient effect of thrombosis is listed in the xience alpine everolimus eluting coronary stent system electronic instructions for use as a known patient effect of coronary stenting procedures.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The additional device referenced is being filed under a separate medwatch report.
Event or Problem Description
It was reported that the patient was admitted emergently with acute myocardial infarction (mi) and hypotension.Coronary angiography was performed and noted a total occlusion of the right coronary artery (rca).The vessel was opened with an unspecified guide wire and unspecified dilatation catheter.Thrombus was noted at the lesion and was treated with an aspiration catheter.Pre-dilatation was performed and the 3.5 x 38 mm xience alpine stent was deployed at the target lesion.A second lesion was noted in the left anterior descending (lad) artery; this was treated with implantation of a 3.0 x 23 mm xience alpine.St elevation was noted and coronary angiography noted thrombus in the 3.5 x 38 mm xience alpine stent implanted in the rca.The thrombus was removed using a filter and an aspiration catheter; however, the thrombus formed again.The patient only received heparin during the procedure, as bleeding was noted coming from the patient's ear and it was thought that there was a possible brain bleed.The activated clotting time (act) was noted to be >300.As the thrombus kept re-forming, a 4.0 x 38 mm xience alpine was implanted within the 3.5 x 38 mm xience alpine; however, the thrombus re-formed.The physician then administered aggrastat.The thrombus was able to be removed and did not recur.The st elevation decreased and the patient stabilized.It was noted that no thrombus formed in the 3.0 x 23 mm xience alpine implanted in the lad.The physician determined that the patient had a hypercoagulability issue and there was no issue with the stents themselves.

• 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: 6068367
• Report Number: 2024168-2016-07446
• Device Sequence Number: 10978791
• Product Code: NIQ
• UDI-Device Identifier: 08717648199578
• UDI-Public: (01)08717648199578(17)190626(10)6061741
• 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: 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): 10/31/2016

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: 06/26/2019
• Device Catalogue Number: 1125350-38
• Device Lot Number: 6061741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2016
• Initial Report FDA Received Date: 10/31/2016
• 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: STENT: 4.0X38 XIENCE ALPINE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Weight: 72