MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1550350-15

Device Problem Device Damaged by Another Device (2915)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Prolapse (2475)

Event Date 06/02/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.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 determined the reported difficulties and treatment appear to be related to circumstances of the procedure as it is likely the guide wire, which was advanced to treat the patient effect of plaque shift (prolapse), interacted with the previously implanted stent causing the reported device damaged by another.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat a lesion in the left anterior descending artery.Following pre-dilatation, a 3.5 x 15 mm xience sierra stent was deployed and post-dilated with a 3.75 x 8 mm balloon catheter.It is unknown when this occurred, but plaque shifted into the diagonal artery.A pressurewire x guide wire was advanced to the diagonal artery; however, it became caught in the deployed stent.The wire was pulled back, but this caused the stent to also pull back into the left main and aorta.The tip of the wire unraveled and separated.The separated portion of the tip of the wire remained attached to the stent.An attempt to snare the stent was made, but unsuccessful.An attempt to advance a 1.2 mm unspecified balloon catheter over the native lad unspecified wire was made; however, the balloon could not advance on the wire.An attempt to remove the stent with a buddy wire system was made but also failed.Another attempt to advance the 1.2 mm unspecified balloon catheter on the wire was made but failed.An attempt to remove the stent with a micro-catheter and dottering technique was made, but failed.The stent was crushed into the left main with a 1.2 mm, 2.0 mm, and 3.0 mm balloon catheters.A 4.0 x 33 mm xience sierra stent was deployed over the crushed stent and post-dilatation was performed with 5.0 x 8 mm non-compliant balloon catheter.The procedure was successfully completed with intravascular ultrasound confirming that the stent was fully apposed.No additional information was provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7620224
• MDR Text Key: 111718490
• Report Number: 2024168-2018-04675
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227417
• UDI-Public: 08717648227417
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2019
• Device Catalogue Number: 1550350-15
• Device Lot Number: 8041741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE: PRESSUREWIREX
• Patient Outcome(s): Required Intervention