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

Catalog Number 1500400-15

Device Problems Patient-Device Incompatibility (2682); Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/22/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(4)-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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.Na.

Event Description

It was reported the procedure was to treat a heavily tortuous and moderately calcified lesion in the left main (lm).The 4.0x15mm rx xience sierra stent delivery system (sds) was advanced to the lesion and the stent deployed.It was noted the stent was not well apposed to the vessel wall and migrated to the iliac artery.The stent was not retrieved and remains in the iliac artery.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported migration and wall apposition could not be replicated in testing environment as it was related to operational context of the procedure.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 incidents from this lot.The investigation was unable to determine a conclusive cause for the reported patient device incompatibility (wall apposition).The reported stent migration appears to be related to operational context of the procedure as it is the reported wall apposition caused the reported stent migration.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: 9250173
• MDR Text Key: 164118397
• Report Number: 2024168-2019-13005
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2021
• Device Catalogue Number: 1500400-15
• Device Lot Number: 8110642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Date Manufacturer Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RUNTHROUGH GUIDE WIRE.; RUNTHROUGH GUIDE WIRE
• Patient Outcome(s): Other