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

Catalog Number	1074350-33
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/25/2017
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.Event date: estimated date of event.Evaluation summary: a visual inspection was performed on the returned device.The reported shaft separation was confirmed.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/noted difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that during preparation of a 3.50 x 33 mm xience xpedition rx stent delivery system (sds), the sds was removed from the dispenser coil loop and it was noted that the hub broke off the shaft.The device was not used and there was no patient involvement.There was no clinically significant delay in 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: 6963603
• Report Number: 2024168-2017-08352
• Device Sequence Number: 19203266
• Product Code: NIQ
• UDI-Device Identifier: 08717648162572
• UDI-Public: 08717648162572
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 10/19/2017

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: 03/05/2020
• Device Catalogue Number: 1074350-33
• Device Lot Number: 7022841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1