MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE ALPINE; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Model Number	1125250-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Stenosis (2263)
Date of Event	03/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation as the stent remains in the patient.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effects of myocardial infarction and stenosis are listed in the xience alpine, everolimus eluting coronary stent system (eecss), instructions for use as known patient effects of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) 2017 the 2.5x38 mm xience alpine stent was implanted in the proximal left anterior descending (plad) coronary artery.On (b)(6) 2017 the 2.5x18 mm absorb gt1 was implanted in the ramus coronary artery.On (b)(6) 2020 the patient had a myocardial infarction and was found to have stenosis near the xience alpine stent.The stenosis was within 5 mm of the xience alpine stent.Percutaneous revascularization was performed and a drug eluting stent was implanted in the plad.The condition is continuing.No additional information was provided.
Additional Manufacturer Narrative
G4: the correct aware date for the initial mdr filed is 3/19/2020.

• Brand Name: XIENCE ALPINE
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9930963
• Report Number: 2024168-2020-03430
• Device Sequence Number: 2718424
• Product Code: NIQ
• UDI-Device Identifier: 08717648199219
• UDI-Public: 08717648199219
• Combination Product (Y/N): Y
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2020

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 Model Number: 1125250-38
• Device Catalogue Number: 1125250-38
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 04/17/2020
• 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: ABSORB GT1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 80 YR
• Patient Weight: 54