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

Catalog Number 1550250-28

Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2019

Event Type  Injury  

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

Event Description

It was reported that after deployment of the 2.50 x 28 mm xience sierra stent in the mid left anterior descending coronary artery, the stent delivery system (sds) was removed.Insufficient stent expansion was confirmed by intravascular ultrasound (ivus) and the sds was attempted to be re-delivered.When air of the sds was being removed in the guiding catheter, backflow of blood was noted, indicating a balloon rupture.No resistance was noted during advancement or removal.There were no adverse patient sequela.There was no clinically significant delay in the procedure.No additional information was provided.

Event Description

Subsequent to the initially filed report the following information was provided: the procedure was to treat a 90% stenosed, mildly calcified lesion in the non tortuous mid left anterior descending coronary artery.The device was prepped outside the anatomy per the instructions for use (ifu) without any issues and was inflated twice, once to 12 atmospheres (atm) for initial stent deployment, and once to 14 atm for the second attempt at deployment.The procedure was completed with an nc traveler balloon dilatation catheter (bdc).No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Corrections: mfr site registration #.Removed device code 2017.Evaluation summary: a visual inspection was performed on the returned device.The reported material rupture was confirmed.The reported difficult to deploy could not be confirmed during return analysis testing due to the noted balloon rupture (condition of the returned device).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.The investigation determined the reported material rupture and subsequent treatment appear to be related to circumstances of the procedure, as it is likely the balloon interacted with the previously deployed stent during retraction, reinsertion and re-advancement of the stent delivery system, as scratches were noted on the balloon, thus causing the reported material rupture (longitudinal balloon rupture at the proximal balloon marker).A conclusive cause for the reported difficult to deploy could not be confirmed during return analysis testing due to the noted balloon rupture.There is no indication of a product quality issue with respect to the design, manufacture 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: 8744885
• MDR Text Key: 149522283
• Report Number: 2024168-2019-05213
• 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: 08/15/2019

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: 07/10/2021
• Device Catalogue Number: 1550250-28
• Device Lot Number: 8063041
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: 07/25/2019
• Supplement Dates FDA Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 70