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

Catalog Number 1550350-38

Device Problems Failure to Advance (2524); Difficult or Delayed Activation (2577); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.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 to treat a moderately tortuous and moderately calcified lesion in the right coronary artery to the posterior lateral artery segment.Following pre-dilatation, a 48mm xience xpedition stent delivery system (sds) was advanced to the segment and was successfully deployed.A 3.5x38mm xience sierra sds was attempted to be advanced to the mid right coronary artery to distal right coronary artery segment; however, the sds became stuck and the stent implant shifted on the balloon.The sds balloon was inflated to expand the proximal part of stent implant and the sds was removed without issue.A mini trek balloon was then used to expand the distal part of the stent.The 3.5x38mm xience sierra sds was deployed within the target lesion.A new 3.5x33mm xience sierra sds was deployed to fully cover the rest of lesion.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the difficult anatomy during advancement to the lesion causing the reported failure to advance and stent movement (unstable stent).The device was then deployed within the target lesion; however, only the proximal portion of the stent was fully expanded causing the reported difficult to deploy and subsequent post-dilatation (additional therapy/non-surgical procedure).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: 8442280
• MDR Text Key: 139534193
• Report Number: 2024168-2019-02239
• 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: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2021
• Device Catalogue Number: 1550350-38
• Device Lot Number: 8032841
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STENT: XIENCE XPEDITION 48MM; STENT: XIENCE XPEDITION 48MM
• Patient Outcome(s): Required Intervention