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

Catalog Number 1500200-33

Device Problems Kinked (1339); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 performed to treat a de novo lesion in the diagonal artery that was below bifurcation with heavy tortuosity and heavy calcification and was 90% stenosed.Pre-dilatation was performed several times using a non-compliant balloon catheter.However, a 2.0 x 38 mm xience sierra stent delivery system (sds) could not cross the target lesion.A decision was made to switch to a shorter stent and a 2.0 x 33 mm sierra sds was used instead, but could also not cross the target lesion when it became stuck in the proximal lesion in the calcium.An attempt was made to pull the sds, and during manipulation the balloon shaft kinked.The 2.0 x 33 mm xience sierra sds was removed and a non-abbott device was used 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 not available for return.Correction: device not returned to manufacturer.(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 sierra everolimus eluting coronary stent system instructions for use states: if removal of a stent system is required prior to deployment, ensure that the guide catheter is coaxially positioned relative to the stent delivery system, and cautiously withdraw the stent delivery system into the guiding catheter.Should unusual resistance be felt at any time when withdrawing the stent into the guide catheter, the stent delivery system and the guide catheter should be removed as a single unit.This should be done under direct visualization with fluoroscopy.In this case, it is unknown if the instructions for use (ifu) deviation related to excessive force may have contributed to the reported event.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported material deformation was confirmed.

Event Description

Subsequent to the initially filed report, the following information was received: during manipulation the stent implant became crushed and mangled.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: 7616628
• MDR Text Key: 111858675
• Report Number: 2024168-2018-04649
• 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,Followup
• Report Date: 07/30/2018

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: 10/12/2020
• Device Catalogue Number: 1500200-33
• Device Lot Number: 7100642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 06/27/2018; 07/25/2018
• Supplement Dates FDA Received: 06/28/2018; 07/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1