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

Catalog Number	1125300-12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	05/06/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Non-healthcare professional.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.A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined.The reported patient effect of hypersensitivity is listed in the xience alpine, everolimus eluting coronary stent system (eecss), instructions for use as a known patient effect 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
It was reported that the procedure was to treat the left anterior descending artery that was approximately 80% stenosed.On (b)(6) 2016, a 3.0 x 12 mm xience alpine stent was implanted; however, the patient began experiencing a rash shortly after the procedure, which has worsened over time.The rash is felt on the underarms, upper thighs, bottom part of the legs and back and occasionally on the left side of the face.The patient stated that the rash and itchy feeling is sporadic.She has been taking gabapentin and another unspecified medication for the rash which make her feel tired.The patient has been consulting her dermatologist and allergist to confirm what is causing the rash.At this time, the cause is undetermined.On (b)(6) 2016, she was re-hospitalized and it was confirmed that the stent had not migrated from the target lesion.The physician stated that two smaller stents may need to be implanted; however, the patient will confirm this with the physician in two weeks.No additional information has been 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: 7823124
• Report Number: 2024168-2018-06667
• Device Sequence Number: 1290939
• Product Code: NIQ
• UDI-Device Identifier: 08717648199332
• UDI-Public: 08717648199332
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/28/2018

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: 11/17/2018
• Device Catalogue Number: 1125300-12
• Device Lot Number: 5111141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 08/28/2018
• 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: 66 YR
• Patient Weight: 70