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

Model Number 1550350-12

Device Problems Defective Device (2588); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The other xience sierra device referenced in b5 is filed under a separate medwatch report number.

Event Description

(b)(6).It was reported that the procedure was performed to treat a lesion in the proximal right coronary artery (rca).The first 3.5 x 12 mm xience sierra stent delivery system was advanced to the target lesion without issue; however, on angiography, the stent delivery system balloon appeared slightly inflated, as if the stent was slightly expanded.The device was removed without difficulty and the stent remained on the delivery system balloon.The second 3.5 x 12 mm xience sierra stent delivery system was then advanced to the target lesion.No difficulty was noted; however, this stent delivery system balloon also appeared slightly inflated, as if the stent was slightly expanded.The device was removed without difficulty and the stent remained on the delivery system balloon.The procedure continued with implantation of a 3.5 x 15 mm xience sierra stent.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

A visual inspection was performed on the returned device.The reported defective device and material deformation was not confirmed as there was no damage noted to the stent implant and the stent implant was stationary on the tightly folded balloon, between the markers.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 issues, as they could not be confirmed during return analysis testing.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

• 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: 10299449
• MDR Text Key: 199688489
• Report Number: 2024168-2020-06032
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227400
• UDI-Public: 08717648227400
• 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: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2020
• Device Model Number: 1550350-12
• Device Catalogue Number: 1550350-12
• Device Lot Number: 9111841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Date Manufacturer Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 112