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

Catalog Number	1125250-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); No Code Available (3191)
Date of Event	05/26/2018
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.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 hypersensitivity is listed in the xience alpine, everolimus eluting coronary stent systems 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.
Event or Problem Description
It was reported that on (b)(6) 2018, a 2.50x15mm xience alpine stent was implanted at the mid left anterior descending artery.The next day ((b)(6) 2018), the patient had shortness of breath.Patient believes this is due to her nickel allergy from the previously implanted stent.No treatment has been reported.Physician has not confirmed allergy diagnosis and is uncertain about device relationship to event.No additional information has been requested.
Event or Problem Description
Subsequent to the initially filed mdr report, a user facility medwatch report was received and additional symptoms of persistent coughing and itchiness were noted by the patient.Additionally, the patient has been patch tested for metal allergies and a severe contact reaction was noted to nickel, cobalt and chromium.Patient confirms patch testing was never done before the procedure and neither did the physician inquire about potential allergies.No additional information was provided.
Additional Manufacturer Narrative
Patient codes: 3191 not labeled.Internal file number - (b)(4).Correction - date of event changed from (b)(6) 2018 to (b)(6) /2018.Correction - implanted date changed from 4/25/2018 to 5/25/2018 correction: mfr site - reg# changed from (b)(4) to (b)(4).

• 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: 8479949
• Report Number: 2024168-2019-02608
• Device Sequence Number: 1019026
• Product Code: NIQ
• UDI-Device Identifier: 08717648199165
• UDI-Public: 08717648199165
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2019

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: 09/20/2020
• Device Catalogue Number: 1125250-15
• Device Lot Number: 7090541
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 08/02/2019
• 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: Other
• Patient Age: 71 YR
• Patient Weight: 78