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

Catalog Number 1550250-12

Device Problems Failure to Advance (2524); Device Dislodged or Dislocated (2923); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2019

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 received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a lesion in the distal circumflex (cx) coronary artery.An unspecified stent had been previously implanted in the proximal cx coronary artery, which was heavily calcified.After pre-dilatation, the 2.5x12mm xience sierra rx stent delivery system (sds) was advanced but would not cross the previously implanted stent due to the heavy calcification.As such, the sds was removed without noted resistance through the guide catheter; however, it was noted that the sds felt different during the removal.Upon removal, it was noted that the stent had dislodged in the previously implanted stent and was migrating toward the left main coronary artery.An unspecified balloon catheter was advanced to try to entrap the stent but was unsuccessful.A snare device was then advanced and successfully retrieved the dislodged stent from the patient anatomy.The case concluded and no additional treatment was provided.There was no adverse patient sequela and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: the stent was returned for analysis.The reported stent dislodgement was confirmed.The reported failure to advance and device operating differently than expected was unable to be replicated in a testing environment as they were based on operational circumstances.A review of the lot history record and complaint history could not be conducted because the lot number was not provided.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure as it is likely the device interacted with the previously implanted stent causing the reported failure to advance.During removal the device interacted with the previously deployed stent causing the reported stent dislodgement and device operating differently than expected with the patient effects of removal of a foreign body and additional thereapy/non-surgical treatment.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

• 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
• MDR Report Key: 8574320
• MDR Text Key: 143854779
• Report Number: 2024168-2019-03479
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1550250-12
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/25/2019
• Date Manufacturer Received: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention