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

Model Number 1550350-08

Device Problem Unintended System Motion (1430)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 06/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.User facility voluntary medwatch mw5087767.

Event Description

It was reported that the procedure was performed to treat a lesion in the proximal right coronary artery.A 3.5x8mm xience sierra stent delivery system (sds) was advanced without resistance, and the stent deployed; however, the stent moved during deployment, and enveloped around an unspecified guiding catheter.An unspecified guide wire and an unspecified balloon dilatation catheter were used to keep the stent from sliding off the guiding catheter as it was being pulled back into the right brachial artery.Once there, the stent was embedded, and the procedure was complete.There was no clinically significant delay in the procedure.No additional information was provided.User facility medwatch report received that states: "coronary stent deployed ostial right coronary artery and migrated up around guide catheter.Stent pulled back and relocated and deployed in right brachial artery.Fda safety report id # (b)(4).".

Manufacturer Narrative

The device was returned for analysis.The reported difficulty to deploy could not be confirmed in a 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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported deflation issues; however, factors that may contribute to deflation issues include, but are not limited to, material damage, interactions with other devices or interaction with lesion calcification and tortuosity.Additionally, it is possible the noted hypotube and inner member damage contributed to the reported difficulties; however, it is unclear if this damage occurred during advancement prior to deployment or during removal.It should be noted, there was no damage or leak noted to the stent delivery system (sds) during the inspection prior to use or during preparation of the device, which suggests a product quality issue did not contribute to the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.Exemption number e2019001.

Manufacturer Narrative

The device was returned for analysis.The reported difficulty to deploy could not be confirmed in a 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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported deployment issues.Additionally, it is possible the noted hypotube and inner member damage contributed to the reported difficulties; however, it is unclear if this damage occurred during advancement prior to deployment or during removal.It should be noted, there was no damage or leak noted to the stent delivery system (sds) during the inspection prior to use or during preparation of the device, which suggests a product quality issue did not contribute to the reported difficulties.There is no indication of a product quality issue with respect to manufacture, design or labeling.Exemption number e2019001-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.Updated wording.

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.

• 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: 8824052
• MDR Text Key: 152117146
• Report Number: 2024168-2019-10327
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227394
• UDI-Public: 08717648227394
• 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,Followup,Followup
• Report Date: 07/20/2020

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: 10/07/2019
• Device Model Number: 1550350-08
• Device Catalogue Number: 1550350-08
• Device Lot Number: 8092841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/24/2019
• Supplement Dates Manufacturer Received: 10/02/2019; 10/18/2019; 07/20/2020
• Supplement Dates FDA Received: 10/14/2019; 10/30/2019; 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 74