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 Loose or Intermittent Connection (1371); Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 the procedure was to treat the circumflex artery that did not have tortuosity or calcification.A 3.5 x 38 mm xience sierra stent delivery system (sds) was used.The device was loaded onto an unspecified guide wire that was inside the anatomy, and an inflation device was used.However, it was noted that there was foreign material on the hub of the sds.The foreign material stayed on the device and did not separate into two separate pieces.Due to this foreign material, the sds could not connect with the inflation device.Another 3.5 x 38 mm xience sierra sds was then 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

Internal file number: (b)(4).Evaluation summary: the device was returned for analysis.The reported foreign material present on device was not confirmed.The reported loose or intermittent connection 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.Although the investigation was unable to confirm the reported foreign material on the hub it is likely the noted flash was identified as foreign material.Therefore, the investigation determined the noted flash appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• 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: 8632017
• MDR Text Key: 145775863
• Report Number: 2024168-2019-04000
• 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: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2020
• Device Catalogue Number: 1550350-38
• Device Lot Number: 9010941
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/15/2019
• Date Manufacturer Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 107