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

Catalog Number	1125250-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2019
Type of Reportable Event	Death
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.The reported patient effect of death 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 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 of the device.
Event or Problem Description
It was reported that on (b)(6) 2017 three xience alpine stents were implanted.A 2.5x23 mm xience alpine stent was implanted in the mid right coronary artery (rca), a 2.5x23 mm xience alpine stent was implanted in the distal rca, and a 2.25x23 mm xience alpine stent was implanted in the ramus coronary artery.On (b)(6) 2019 the patient expired of unknown cause at home.In the opinion of the physician, the death is unlikely related to the xience alpine stent.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Correction: case details, concomitant medical products.
Event or Problem Description
Correction to the previously filed report, it was a 3.5x38 mm xience alpine stent that was implanted in the mid right coronary artery.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Corrections: results code, conclusion code were removed and replaced.Correction: patient code was removed replaced (b)(4).No specified device issue has been reported at this time.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
Subsequent to the previously filed report, additional information was received that the death certificate lists the cause of death as coronary artery disease.In the opinion of the physician, this event is not related to the xience alpine stent.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: 8298710
• Report Number: 2024168-2019-00783
• Device Sequence Number: 16631090
• Product Code: NIQ
• UDI-Device Identifier: 08717648199189
• UDI-Public: 08717648199189
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup,Followup
• Report Date (Section B): 06/04/2019

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 Expiration Date: 02/15/2020
• Device Catalogue Number: 1125250-23
• Device Lot Number: 7012661
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 02/05/2019; 05/21/2019
• Initial Report FDA Received Date: 02/01/2019
• Supplement Report FDA Received Date: 02/11/2019; 06/04/2019
• 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: XIENCE ALPINE STENTS: 2.25X23, 2.5X23
• Outcome Attributed to Adverse Event: Death
• Patient Age: 60 YR
• Patient Weight: 139