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

Catalog Number	1125325-38
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: a visual and functional inspection was performed on the returned device.The reported inflation issue, leak, and failure to deploy were unable to be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the sds was not securely attached to the inflation device resulting in the reported failure to deploy, inflation issue, and leak.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported the procedure was to treat a lesion in an unspecified artery.The 3.25x38 mm xience alpine stent delivery system (sds) was advanced without resistance in the patient anatomy.However, the balloon failed to inflate; the stent did not deploy.A leak was suspected.The sds was removed from the patient anatomy.A new xience alpine was used to complete the procedure.There were no adverse patient effects.There was no clinically significant delay in the procedure.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: 7140085
• Report Number: 2024168-2017-10068
• Device Sequence Number: 1108900
• Product Code: NIQ
• UDI-Device Identifier: 08717648199486
• UDI-Public: 08717648199486
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/04/2020
• Device Catalogue Number: 1125325-38
• Device Lot Number: 7062741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR