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

Catalog Number	1125300-18
Health Effect - Clinical Codes	Angina (1710); Thrombosis (2100)
Date of Event	07/26/2017
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.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.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.The reported patient effects of angina and thrombosis are listed in xience alpine everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.The investigation determined a conclusive cause for the reported difficulty to deploy could not be determined.Additionally, a conclusive cause for the reported patient effects and the relationship to the product, if any, could not be determined and there is no indication of a product quality issue with respect to manufacture, design or labeling.The other xience alpine referenced is filed under a separate medwatch report.
Event or Problem Description
It was reported that on (b)(6) 2017, the patient underwent a coronary procedure.An atherectomy device, followed by a cutting balloon was used to pre-treat the proximal to distal right coronary artery (rca).A 2.5 x 38 mm xience alpine stent was deployed in the mid to distal rca and a 3.0 x 18 mm xience alpine stent was deployed in the proximal to mid rca.The stents were deployed in an overlapping manner.Post dilatation was performed.Optical frequency domain imaging (ofdi) was performed and noted that the proximal edge of the 3.0 x 18 mm xience alpine stent was slightly malapposed; however, this was deemed acceptable and the procedure was completed.The patient was discharged to home on (b)(6) 2017.On (b)(6) 2017, the patient began to experience exertional chest pain, and on (b)(6) 2017, experienced chest pain at rest.The patient was re-hospitalized.Coronary angiography and intravascular ultrasound (ivus) noted in-stent thrombosis, starting at the proximal edge of the 3.0 x 18 mm xience alpine stent, and extending to both stents.Intervention was performed, with thrombus aspiration and balloon angioplasty.Coronary angiography performed on (b)(6) 2017 noted no anomalies and the patient was discharged to home on the following day.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: 6828729
• Report Number: 2024168-2017-07064
• Device Sequence Number: 67788
• Product Code: NIQ
• UDI-Device Identifier: 08717648199356
• UDI-Public: 08717648199356
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/29/2017

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: 02/27/2020
• Device Catalogue Number: 1125300-18
• Device Lot Number: 7021461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2017
• Initial Report FDA Received Date: 08/29/2017
• 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: 68 YR
• Patient Weight: 70