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

Catalog Number	1125250-38
Health Effect - Clinical Codes	Angina (1710); Thrombosis (2100)
Date of Event	01/21/2017
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.Concomitant medical products: stent: 3.0 x 15 mm xience alpine.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined a conclusive cause for the reported difficulties cannot be determined.However, angina and thrombosis are listed in the xience alpine everolimus eluting coronary stent systems instructions for use as known patient effect(s) of coronary stenting procedures.Additionally, 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 3.0x15 referenced is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a mildly tortuous mid right coronary artery (rca).On (b)(6) 2017, the patient presented with a st elevated myocardial infarction (stemi).Pre-dilatation was performed with a 2.5 x 28 and a 3.0 x 15 mm unspecified balloon catheter.A 2.5 x 38 mm and a 3.0 x 15 mm xience alpine stents were deployed.Post-dilatation was performed with a 3.25 x 35 mm nc balloon catheter.Final angiography confirmed the stents were fully apposed to the vessel.There was some resistance removing the non-abbott guide wire from the anatomy at the completion of the procedure.The patient was put on dual anti-platelet therapy.On (b)(6) 2017, the patient returned to the cath lab with chest pain and angiography confirmed there was in-stent thrombosis in the entire length of the xience alpine stents.It was believed that when there was resistance removing the guide wire that it damaged the distal end of the distal stent.There was difficulty advancing through the thrombus so a 1.5 x 10 mm and then a 2.0 mm balloon were used for dilatation and a 2.25 x 28 mm xience alpine and a 2.5 x 18 mm xience alpine stent were successfully used to complete the procedure.Patient is fine.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: 6289631
• Report Number: 2024168-2017-00795
• Device Sequence Number: 675026
• Product Code: NIQ
• UDI-Device Identifier: 08717648199219
• UDI-Public: (01)08717648199219(17)191207(10)6112841
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 01/31/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/07/2019
• Device Catalogue Number: 1125250-38
• Device Lot Number: 6112841
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2017
• Initial Report FDA Received Date: 01/31/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 58 YR