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

Catalog Number 1550400-18

Device Problems Material Rupture (1546); Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: guide wire: sion blue, guide catheter: 6fr spb 3.5.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 emergent procedure was performed to treat a concentric lesion in the distal left circumflex coronary artery with no tortuosity, no calcification and 90% stenosis in a patient with acute coronary syndrome.A 4.00 x 18 mm xience sierra stent delivery system (sds) was advanced to the lesion with no resistance.On attempting to inflate the balloon to deploy the stent of the sds, the pressure gauge of the unspecified indeflator did not move.Continued pressure was applied and the gauge reached 10 atmospheres; however, the pressure was not maintained.The stent was deployed at the target lesion and the sds was removed without issue.Outside of the anatomy, a balloon rupture of the sds was noted.Intravascular ultrasound noted that the stent was dilated unevenly with the proximal portion at 2.0 mm in diameter compared to 4.0 mm in diameter distally.An unspecified non-complaint balloon catheter was used successfully to complete the procedure.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number: (b)(4).Evaluation summary: the device was returned for analysis.The reported material rupture was confirmed.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 determined the reported material rupture and difficulty to deploy appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• 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: 8437718
• MDR Text Key: 139365302
• Report Number: 2024168-2019-02183
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

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: 04/11/2021
• Device Catalogue Number: 1550400-18
• Device Lot Number: 8032641
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/08/2019
• Initial Date Manufacturer Received: 02/24/2019
• Initial Date FDA Received: 03/20/2019
• Supplement Dates Manufacturer Received: 04/11/2019
• Supplement Dates FDA Received: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention