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

Catalog Number 1011707-33

Device Problems Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a mildly tortuous and moderately calcified lesion in the tibial artery.An attempt to advance a 2.5x33mm xience prime stent delivery system (sds) over a.014 command guide wire was made; however, the guide wire was not properly lubricated and resistance was felt.An attempt to remove the sds was made, but the shaft separated.Difficult removing the sds from the guide wire was felt.The procedure was successfully completed with another unspecified xience stent and the same.014 command guide wire.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis, the reported material separation was confirmed.The reported difficult to advance and to remove were not able to be confirmed due to returned device condition.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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the guide wire as it was reportedly not properly lubricated during advancement causing the reported difficulty to advance.Device removal was attempted; however, the guide wire once again interacted with the device causing the reported difficulty to remove and subsequent material separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• Brand Name: RX PRIME LL
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10497634
• MDR Text Key: 214617704
• Report Number: 2024168-2020-07424
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2022
• Device Catalogue Number: 1011707-33
• Device Lot Number: 9050741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Date Manufacturer Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: .014 COMMAND GUIDE WIRE
• Patient Age: 74 YR
• Patient Weight: 90