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

Model Number 1550275-12

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2020

Event Type  Injury  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a lesion located in the heavily tortuous proximal circumflex artery that was heavily calcified and 99% stenosed.After lesion preparation, a xience sierra was delivered but during deployment, the delivery balloon ruptured at 10 atmospheres.As the stent was not expanded enough, post-dilatation was performed with a non-abbott balloon to successfully complete the procedure.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

A visual and functional inspection was performed on the returned stent delivery system (sds).The reported balloon rupture 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 other similar incidents and/or complaints reported from this lot.Balloon material ruptures can be affected by numerous factors such as balloon damage during processing, balloon material, inflation technique, inflation over rated burst pressure, interactions with other devices, anatomical conditions, a previously implanted stent or insufficient preparation prior to use.The device was prepped prior to use without any leak or ruptures noted, which would suggest that the device was not damaged prior to use.The investigation was unable to determine a conclusive cause for the reported balloon rupture.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: 10341713
• MDR Text Key: 201451525
• Report Number: 2024168-2020-06309
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227165
• UDI-Public: 08717648227165
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2021
• Device Model Number: 1550275-12
• Device Catalogue Number: 1550275-12
• Device Lot Number: 8051741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Initial Date Manufacturer Received: 07/08/2020
• Initial Date FDA Received: 07/29/2020
• Supplement Dates Manufacturer Received: 08/04/2020
• Supplement Dates FDA Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention