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

Model Number 1550350-23

Device Problems Defective Device (2588); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a left anterior descending lesion.A 3.50x23mm xience sierra crossed the lesion and was attempted to be implanted.However, during deployment, it was noted that the stent had shortened and did not expand as expected.The xience sierra was simply removed and another unspecified stent 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.

Event Description

It was reported that the procedure was to treat a left anterior descending lesion.A 3.50x23mm xience sierra crossed the lesion and was attempted to be implanted.However, during deployment, it was noted that the stent had shortened and did not expand as expected.The xience sierra was simply removed and another unspecified stent was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Additional information received subsequent to filing the initial report states that the xience sierra partially deployed, remaining on the delivery system.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.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 similar incidents and/or complaints reported from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

• 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: 10341269
• MDR Text Key: 201022283
• Report Number: 2024168-2020-06302
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227431
• UDI-Public: 08717648227431
• 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: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2021
• Device Model Number: 1550350-23
• Device Catalogue Number: 1550350-23
• Device Lot Number: 805304A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 53