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

Model Number 1550350-38

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Patient Involvement (2645)

Event Date 01/05/2021

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.

Event Description

It was reported that during unpacking of a 3.50x38 xience sierra, it was noted that the stent implant had dislodged (was only partially on the balloon) still remaining on the stent delivery catheter.The device was not used and there was no patient involvement.Another xience sierra was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

A visual and dimensional inspection was performed on the returned device.The reported stent dislodgement 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 identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported stent dislodgement.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE SIERRA 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: 11205388
• MDR Text Key: 227917815
• Report Number: 2024168-2021-00570
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227462
• UDI-Public: 08717648227462
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2021
• Device Model Number: 1550350-38
• Device Catalogue Number: 1550350-38
• Device Lot Number: 0012141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 01/20/2021
• Supplement Dates Manufacturer Received: 01/27/2021
• Supplement Dates FDA Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1