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

Catalog Number	1125275-15
Health Effect - Clinical Codes	Angina (1710); Hypersensitivity/Allergic reaction (1907)
Date of Event	08/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Medical devices: stent: xience alpine 3.0x15mm(rca), 3.0x28mm, 3.0x15mm(cx).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.The reported patient effect(s) of angina and hypersensitivity are listed in the xience alpine everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, 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.
Event or Problem Description
It was reported that the patient underwent a successful procedure on (b)(6) 2015 during which one xience alpine stent (3.0 x 15 mm) was deployed successfully in the right coronary artery (rca).Approximately 2-3 months ago the patient began to experience shortness of breath.A stress test confirmed new lesions/blockages located in the circumflex (cx) and the left anterior descending (lad) artery.The stent implant located in the rca was patent.Although the patient had triple artery disease, the decision was made not to perform triple coronary artery bypass, but to perform stenting.On (b)(6) 2017, the patient underwent a new procedure for treatment of the cx and lad.Two xience alpine stents (3.0 x 28 mm and 3.0 x 15 mm) were placed in the cx and one xience alpine stent (2.75 x 15 mm) was placed in the lad.Since that procedure the patient has been experiencing a sensation of tightness in the chest and has to breathe deeply to catch his breath.An ekg was performed; however, nothing of note was found.On (b)(6) 2017, the patients plavix was changed to brilinta.The patient has been feeling light headed with tightness across the chest and also has observed red blotches on his chest.No treatment at this time has been performed.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: 6854207
• Report Number: 2024168-2017-07379
• Device Sequence Number: 496308
• Product Code: NIQ
• UDI-Device Identifier: 08717648199257
• UDI-Public: 08717648199257
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: consumer
• Initial Reporter Occupation: Patient
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/08/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/17/2020
• Device Catalogue Number: 1125275-15
• Device Lot Number: 7051041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2017
• Initial Report FDA Received Date: 09/08/2017
• 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: Other
• Patient Age: 67 YR
• Patient Weight: 79