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

Catalog Number	1145250-18
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	02/04/2019
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.Implant date: estimated.The device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the lot number was not provided.The reported patient effect of stenosis is listed in the xience alpine, everolimus eluting coronary stent system 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; however, the subsequent treatments appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.The additional xience alpine and 2 xience sierra devices referenced are being filed under separate medwatch reports.
Event or Problem Description
It was reported that in (b)(6) 2017, the patient presented with ischemic cardiomyelopathy and underwent a coronary stenting procedure for a lesion in the proximal to mid left anterior descending (lad) coronary artery with 80-90% stenosis.A 2.50 x 18 mm xience alpine stent was deployed in the mid lad and a 2.75 x 12 mm xience alpine stent was deployed in the proximal to mid lad without issue.On (b)(6) 2019, the patient underwent further percutaneous coronary transluminal angioplasty (ptca) for unspecified symptoms.In stent re-stenosis of the alpine stents was diagnosed by angiogram.A 3.00 x 28 mm xience sierra stent and a 3.00 x 23 mm xience sierra stent were deployed in the proximal to mid lad to treat the re-stenosis.The patient was reported to be well post procedure and was therefore discharged; however 5 days later the patient developed chest pain and low blood pressure and was re-admitted (b)(6) 2019).Angiogram confirmed in stent thrombosis and the patient was treated with medication and additional balloon angioplasty.A non-abbott heart pump was used during the procedure.Post procedure the stents were confirmed to be patent and the patient was reported to be stable in hospital.No additional information was provided.

• Brand Name: XIENCE ALPINE OTW 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: 8360396
• Report Number: 2024168-2019-01323
• Device Sequence Number: 13882383
• Product Code: NIQ
• UDI-Device Identifier: 08717648199899
• UDI-Public: 08717648199899
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2019

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 Catalogue Number: 1145250-18
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 02/21/2019
• 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: 59 YR
• Patient Weight: 95