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

Catalog Number	1125300-38
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2016
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.(b)(4).The device was not returned for analysis.The device was not prepared for use prior to insertion into the patient anatomy.The xience alpine everolimus eluting coronary stent system, instructions for use states to flush the guide wire lumen and remove air from the system prior to use in the patient.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 reported from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.It is likely that the balloon interacted with the calcified patient anatomy upon inflation attempt, such that it became damaged (scratched) and ruptured as a result.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 90% stenosed, moderately tortuous, and heavily calcified lesion in the distal right coronary artery.Following pre-dilatation, a 3.0x38mm xience alpine stent delivery system was advanced to the lesion.Air aspiration was performed while the device was inside the patient.The balloon ruptured at 8 atmospheres (atm) during the first inflation.The stent delivery system was removed and the stent was successfully post-dilated with a non-abbott balloon dilatation catheter at 20 atm.There was no clinically significant delay in the procedure and no 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: 6234478
• Report Number: 2024168-2017-00224
• Device Sequence Number: 10869406
• Product Code: NIQ
• UDI-Device Identifier: 08717648199332
• UDI-Public: (01)08717648199332(17)170205(10)5013041
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/09/2017

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: 02/05/2017
• Device Catalogue Number: 1125300-38
• Device Lot Number: 5013041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2016
• Initial Report FDA Received Date: 01/09/2017
• 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: GUIDE WIRE: SIONGUIDE CATH: HYPERION