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

Catalog Number 1128300-28

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Patient Involvement (2645)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The xience proa device is currently not commercially available in the u.S., however, it is similar to a device sold in the u.S.

Event Description

It was reported before use of a 3.0x28mm xience proa the physician removed the protective wire stylet, the stent was not on the balloon but on the protective wire stylet.Another xience proa was used to successfully complete the procedure.There were no patient involvement, and no significant clinically delay.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported stent dislodgement 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 were crimp marks visible on the balloon between the balloon markers, suggesting the stent was originally positioned correctly and securely at the time of manufacture, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that inadvertent mishandling during sheath/stylet removal resulted in the reported stent dislodgement.The noted smashed stent implant and the noted multiple kinks on the inner member and outer member likely occurred due to handling or during packing for return analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• Brand Name: XIENCE PROA 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: 10648979
• MDR Text Key: 210433140
• Report Number: 2024168-2020-08374
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2023
• Device Catalogue Number: 1128300-28
• Device Lot Number: 0052641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1