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

Catalog Number	1125225-23
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2018
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 incident information was reviewed; however, the device was not returned for analysis.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 device interacted with the guide wire due to a build-up of procedural contaminates on the guide wire resulting in the reported difficulty to advance and remove the sds.Additionally, the interaction with the guide wire and subsequent difficulties caused the additional identified damage to the device.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat a calcified lesion in the mid circumflex coronary artery.A 2.25 x 23 mm xience alpine stent delivery system (sds) was advanced but met resistance with an unspecified guide wire and became stuck.The shaft of the sds was noted to bunch.The sds and the guide wire were removed together as a single unit.The procedure was successfully completed with an unspecified guide wire and a non-abbott stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date rec¿d by mfr: report source.(b)(4).Root cause summary updated.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the guide wire due to a build-up of procedural contaminates on the guide wire resulting in the reported difficulty to advance and remove the sds.Additionally, the interaction with the guidewire and subsequent difficulties caused the additional identified damage to the stent.There is no indication of a product quality issue with respect to manufacture, design or labeling.Attachment: user facility (voluntary / mandatory) medwatch report number: mw5080213.Attachment: [user facility medwatch report 359500-1-1 rve_1-009001ea4803ec9ab.Pdf.
Event or Problem Description
Subsequent to the initial/final filed report, the following information was received: a user facility medwatch report was received with event status serious injury, required intervention and reported "while md was deploying a cardiac stent, the stent would not slide off the guidewire and began to bunch up on the wire.The md was able to slide it back on the guidewire and removed it without damage to the patient." follow-up with the account confirmed that the stent delivery system (sds) shaft was inadvertently reported as being bunched when it was in fact the stent that had bunched; however, the wire, stent and sds were removed together as a single unit requiring no further intervention as initially reported.There were no reported adverse patient effects.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: 7974547
• Report Number: 2024168-2018-07967
• Device Sequence Number: 13824850
• Product Code: NIQ
• UDI-Device Identifier: 08717648199097
• UDI-Public: 08717648199097
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2018

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: 02/15/2021
• Device Catalogue Number: 1125225-23
• Device Lot Number: 8020641
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR