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

Catalog Number 1500350-38

Device Problems Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(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 relevant information.

Event Description

It was reported that the procedure was to treat an unspecified coronary artery.A 3.5 x 38 mm xience sierra stent delivery system was advanced; however, during post-deployment it was noted that the stent was missing.Due to poor imaging in the cath lab, the missing stent was not noticed during advancement.Intravascular ultrasound was used; however, the stent could not be found in the anatomy.A check of the dispenser coil found that the stent had come off the delivery system in the coil and was never on the balloon when deploying.Reportedly the site thought it was possible that in prepping the device, they inflated the balloon marginally but not enough to dislodge the stent from the balloon.Therefore, an unspecified xience sds was used to successfully complete the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Additional information: serial# added.Evaluation summary: the device was returned for analysis.The reported stent dislodgement was confirmed.It should be noted that the xience sierra everolimus eluting coronary stent system (eecss), instructions for use, notes: do not prepare or pre-inflate the delivery system prior to stent deployment other than as directed.Additionally, it states: prior to using the xience sierra eecss, carefully remove the system from the package and inspect for bends, kinks, and other damage.Verify that the stent does not extend beyond the radiopaque balloon markers.Do not use if any defects are noted.However, do not manipulate, touch, or handle the stent, which may cause coating damage, contamination, or stent dislodgement from the delivery balloon.In this case, it appears that the deviation related to incorrect prep (pre-inflation) may have contributed to the reported stent dislodgement.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 appear to be related to user error.Additionally, the dislodgement was not identified until after insertion into the anatomy indicating the required visual inspection prior to insertion into the anatomy was not performed (against instructions for use).There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 8562071
• MDR Text Key: 143576053
• Report Number: 2024168-2019-03382
• 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: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/29/2021
• Device Catalogue Number: 1500350-38
• Device Lot Number: 8112641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Date Manufacturer Received: 05/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1