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

Model Number	1074350-33
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2017
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.Concomitant products: guide wire: 014 ht versaturn f 190 hc; guide catheter: heartrail 3.5.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 identified no other incidents from this lot.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.The ht versaturn device referenced is being filed under a separate manufacturing report number.
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified, 90% stenosed, 30mm-long lesion in the moderately tortuous proximal left anterior descending (lad) coronary artery.After crossing the lesion with a 014 hi-torque (ht) versaturn f 190 hc guide wire, a 2.5mm non-abbott balloon dilatation catheter was advanced over the versaturn and pre-dilatation was performed.A 3.5x33mm rx xience xpedition stent delivery system (sds) was then advanced over the versaturn, but, prior to exiting the guiding catheter, resistance was met between the xience xpedition and the versaturn.When attempting to retract the xpedition over the versaturn, resistance was also felt between these two devices.Thus, both devices were removed as a single unit.A non-abbott guide wire was advanced, followed by advancement and deployment of a 3.5x33mm non-abbott stent.There were no adverse patient effects and no occurrence of a clinically significant delay.No additional information was provided.

• Brand Name: XIENCE XPEDITION 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: 6712728
• Report Number: 2024168-2017-05887
• Device Sequence Number: 11022860
• Product Code: NIQ
• UDI-Device Identifier: 08717648162572
• UDI-Public: (01)08717648162572(17)190330(10)6032441
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2017

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: 03/30/2019
• Device Model Number: 1074350-33
• Device Catalogue Number: 1074350-33
• Device Lot Number: 6032441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2017
• Initial Report FDA Received Date: 07/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1