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	10/15/2016
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.Concomitant medical products: guide wire: rinato; guide catheter: heartrail 6f jl3.5.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.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.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.
Event or Problem Description
It was reported on 10/06/2016, the patient presented in the emergency room with angina.The coronary procedure was performed to treat a 99% stenosis in the proximal left anterior cx artery.Pre-dilatation was performed with a 1.5 x 6 mm and 2.0 x 13 mm balloon dilatation catheters (bdc).The lesion was measured using intravascular ultrasound (ivus) and a 2.5 x 38 mm xience alpine stent was implanted at 14 atmospheres.Ivus revealed in-stent protrusion, which was treated with a 3.0 x 13 mm bdc.Ivus was re-advanced to the lesion and although there was a slight protrusion remaining, blood flow had been improved.The procedure was completed without further treatment.On (b)(6) 2016, the patient was discharged from the hospital.On (b)(6) 2016, the patient presented with chest pain, which subsided in the same day.On (b)(6) 2016, the patient was re-hospitalized for another procedure to treat a different lesion in the right coronary artery (rca) on (b)(6) 2016.Angiography revealed in-stent thrombosis in the proximal portion of the 2.5 x 38 mm xience alpine stent implant, which was treated with a 3.25 x 15 mm trek bdc.Although the patient still remains in the hospital, the patient condition is improved and stable now.The physician considers that the protrusion possibly caused the in-stent thrombosis, because it was not completely gone and the thrombosis was observed in the same part as the protrusion remained.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: 6114747
• Report Number: 2024168-2016-08123
• Device Sequence Number: 974371
• Product Code: NIQ
• UDI-Device Identifier: 08717648199219
• UDI-Public: (01)08717648199219(17)190301(10)6022241
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2016

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: 03/01/2019
• Device Catalogue Number: 1125250-38
• Device Lot Number: 6022241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2016
• Initial Report FDA Received Date: 11/18/2016
• 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
• Patient Age: 65 YR
• Patient Weight: 62