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 Insert (1316); Leak/Splash (1354); Product Quality Problem (1506); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2019

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.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the 2.25x23 mm xience sierra stent delivery system (sds) was difficult to load on the guide wire.When it was advanced to the distal left anterior descending coronary artery, it did not feel right.Attempt was made to deploy the xience at the lesion, but it would not deploy.After the sds was removed from the anatomy, attempt was made to deploy it and contrast was noted coming out the distal end of the hypotube.Another same size xience sierra was used to complete the procedure without further incident.There were no adverse patient effects and no clinically significant delay in the procedure.There was no additional information provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: the device was returned and analysis was performed.The reported physical property issue, leak and failure to deploy were confirmed.The reported difficulty to insert was not confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.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.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: 8449394
• MDR Text Key: 139750955
• Report Number: 2024168-2019-02298
• 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: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• 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: 03/08/2019
• Date Manufacturer Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1