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

Catalog Number 1550225-23

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2019

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 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 to treat a heavily calcified mid left anterior descending artery.An unknown balancemiddle weight (bmw) guide wire (gw) was advanced to the lesion without issue.A 2.25x23mm xience sierra stent delivery system (sds) was attempted to be advanced over the gw but could not and got stuck on the gw.Force was applied and the sds was able to be removed.The gw was removed separately, wiped down and re-used with and an unspecified same size non-abbott sds to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Device codes: 2976 labeled.Internal file number - (b)(4).Correction: device code 2017 removed.Evaluation summary: the device was returned for analysis.The reported difficulty to position and difficulty to remove were not confirmed; however, the reported material deformation of the stent 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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.Stent damage occurred during the removal as the device was pulled back and interacted with the guide wire causing the reported material deformation (stent damage).There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initially filed mdr, the following information was received: the stent became damaged (flared/bent/kinked) when the sds was being pulled back after the sds became stuck on the guide wire.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
• MDR Report Key: 8587033
• MDR Text Key: 144298860
• Report Number: 2024168-2019-03586
• 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: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2019
• Device Catalogue Number: 1550225-23
• Device Lot Number: 8091341
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/06/2019
• Initial Date Manufacturer Received: 04/19/2019
• Initial Date FDA Received: 05/07/2019
• Supplement Dates Manufacturer Received: 06/12/2019
• Supplement Dates FDA Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALANCEMIDDLE WEIGHT; BALANCEMIDDLE WEIGHT
• Patient Age: 74 YR
• Patient Weight: 111