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

Catalog Number	1125275-38
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was returned for analysis.Visual and functional inspections were performed on the returned device.The leak was confirmed due to a tear in the guide wire exit notch.This type of mechanical damage can occur if an attempt is made to pull the stent delivery system (sds) in an opposite direction as the guide wire.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as the sds and guide wire were likely inadvertently handled during advancement, resulting in the noted tear.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 identified no other similar incidents from this lot.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the mid left anterior descending coronary artery that was moderately tortuous and heavily calcified.Rotablation and guideliners were used.The 2.75 x 38 xience alpine stent crossed the lesion but when it was attempted to be inflated, it was leaking at the junction of the hypotube.It was confirmed that no air was in the patient from the leaky shaft.The procedure was completed by deploying a non-abbott 2.75 x 30 mm stent and a 2.75 x 23 mm xience alpine stent.There were no reported adverse patient effects and 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: 6281189
• Report Number: 2024168-2017-00694
• Device Sequence Number: 443171
• Product Code: NIQ
• UDI-Device Identifier: 08717648199301
• UDI-Public: (01)08717648199301(17)190426(10)6041541
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/26/2017

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: 04/26/2019
• Device Catalogue Number: 1125275-38
• Device Lot Number: 6041541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2017
• Initial Report FDA Received Date: 01/26/2017
• 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: OTHER: GUIDELINER
• Patient Age: 84 YR