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

Model Number 1550300-15

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.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 lesion located in the proximal left anterior descending coronary artery that was non-tortuous, moderately calcified and 70% stenosed.The xience sierra stent was successfully deployed at 16 atmospheres for 20 seconds; however, during deployment, it was noted that the proximal segment of the balloon appeared elongated beyond the proximal marker.There was no adverse patient effect or a clinically significant delay.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 similar incidents from this lot.Images were reviewed and it was noted that when a balloon is inflated past nominal pressure, in this case to 16 atmospheres which is the rated burst pressure, the balloon can grow longitudinally and typically in the proximal region first which is by design.The investigation was unable to determine a conclusive cause for the reported device issue.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE SIERRA
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9608590
• MDR Text Key: 175687084
• Report Number: 2024168-2020-00793
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227257
• UDI-Public: 08717648227257
• Combination Product (y/n): N
• 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: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2020
• Device Model Number: 1550300-15
• Device Catalogue Number: 1550300-15
• Device Lot Number: 9071641
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR