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

Catalog Number 1500250-33

Device Problems Inflation Problem (1310); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that during use of the 2.50x33 xience sierra stent delivery system (sds), contrast was injected and leaked from the metal tubing.The balloon was unable to be inflated.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001.The device was returned for analysis.The reported inflation issues and leak were 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 leak; however, factors that may contribute to leaks include, but are not limited to, material damage, interactions with other devices or interaction with lesion calcification and tortuosity.The reported inflation issues appear to be related to operational context of the procedure as it is likely the leak caused the reported inflation issues.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Additional information received indicates that the lesion was an in-stent restenosis in the left circumflex (lcx) coronary artery with no significant tortuosity.The stent was in the lcx positioned for deployment when it would not inflate.The leak was noted in the hub of the device.No additional information was provided.

• 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: 8952377
• MDR Text Key: 170939426
• Report Number: 2024168-2019-11365
• Device Sequence Number: 1
• Product Code: NIQ
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2022
• Device Catalogue Number: 1500250-33
• Device Lot Number: 8121341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1