MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE PRO 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1017300-48

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2021

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The xience pro 48 is currently not commercially available in the us; however, it is similar to a device sold in the us.Na.

Event Description

It was reported that while advancing a 3x48mm xience pro 48 drug eluting stent (des) shaft through the half open hemostatic valve, the hypotube broke in the hands of the operator.The stent remained in the guiding catheter.The broken hypotube pieces and stent were retrieved without issue.There was no adverse patient effect and no clinically significant delay in the procedure.Another xience 48 was used successfully to complete the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported material separation was able to be confirmed.Additionally, the following was noted: multiple hypotube bends, kinked outer member, kinked shaft and kinked bayonet/support skive.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.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement inadvertent mishandling resulted in the noted multiple device damages (multiple hypotube bends, kinked outer member, kinked shaft and kinked bayonet/support skive) and ultimately resulted in the reported/noted hypotube material separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.D4: lot number, expiration date.H4: manufacture date.

• Brand Name: XIENCE PRO 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11298484
• MDR Text Key: 232386634
• Report Number: 2024168-2021-00994
• 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: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2022
• Device Catalogue Number: 1017300-48
• Device Lot Number: 9121141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Date Manufacturer Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1