MAUDE Adverse Event Report: ABBOTT VASCULAR RX XPEDITION LL; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Model Number	1074300-38
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event - estimated.The device is expected to be returned for evaluation.It has not yet been received.A follow-up will be submitted with all relevant information.
Event or Problem Description
It was reported that the shaft of a 3.0x38mm xience xpedition stent delivery system (sds) snapped during advancement over an unspecified guide wire.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported material separation was able to be 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 identified no other incidents from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported/noted difficulties appear to be related to circumstances of the procedure as it is likely that during advancement inadvertent mishandling resulted in the noted multiple bends and kinks to the entire length of the hypotube and ultimately resulted in the reported material separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.B3: estimated date of event.

• Brand Name: RX XPEDITION LL
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9820954
• Report Number: 2024168-2020-02294
• Device Sequence Number: 1367381
• Product Code: NIQ
• UDI-Device Identifier: 08717648162381
• UDI-Public: 08717648162381
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2020

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: 08/07/2022
• Device Model Number: 1074300-38
• Device Catalogue Number: 1074300-38
• Device Lot Number: 9080141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1