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

Catalog Number	1074400-18
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2018
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.(b)(4).The device was returned for analysis.The reported difficulty to remove the device was unable to be replicated in a testing environment due to the condition of the returned device.The xience xpedition everolimus eluting coronary stent system, instructions for use (ifu), states: failure to follow steps and / or applying excessive force to the delivery system can potentially result in loss of or damage to the stent and / or delivery system components.The ifu deviation does not appear to have caused or contributed to the reported difficulty to remove.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 the reported difficulties appear to be related to circumstances of the procedure as it is likely the deflated balloon interacted with the guiding catheter causing the reported difficulty to remove.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 performed to treat a lesion in the proximal right coronary artery (rca).A prowater guide wire was advanced in the vessel.Pre-dilatation was performed.A 4.0 x 18 mm xience xpedition stent was deployed at the target lesion; however, the deflated balloon could not be withdrawn into the guiding catheter.All the devices were removed as a single unit into the descending aorta to safely apply force to retract the sds and it was removed from the guiding catheter with a lot of resistance.Post-dilatation was accomplished by using an exchange wire and re-wiring of the vessel with good angiographic results.There was no adverse patient effects and no clinically significant delay in the procedure.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: 7328405
• Report Number: 2024168-2018-01698
• Device Sequence Number: 16173038
• Product Code: NIQ
• UDI-Device Identifier: 08717648162640
• UDI-Public: 08717648162640
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2018

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: 11/07/2020
• Device Catalogue Number: 1074400-18
• Device Lot Number: 7110241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1