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

Catalog Number 1550350-18

Device Problems Product Quality Problem (1506); Device Dislodged or Dislocated (2923)

Patient Problem No Patient Involvement (2645)

Event Date 08/15/2018

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 additional relevant information.

Event Description

It was reported that before use, it was noted that the tip of a 3.5 x 18 mm xience sierra stent delivery system was deformed.Therefore, the device was not used in the anatomy.The procedure was completed with the implantation of another 3.5 x 18 mm xience sierra.No additional information was provided.Returned device analysis revealed that the stent moved distally from the proximal marker.

Event Description

Subsequent to the initial report, additional information was received.The tip damage was noted during stylet removal.No additional information was provided.

Manufacturer Narrative

(b)(4).A visual inspection was performed on the returned device which revealed that the stent had moved distally from the proximal marker.The reported physical property issue 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 physical property issue was related to circumstances of the procedure.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: 7909839
• MDR Text Key: 121863527
• Report Number: 2024168-2018-07396
• 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: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2019
• Device Catalogue Number: 1550350-18
• Device Lot Number: 8041942
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/04/2018
• Date Manufacturer Received: 10/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1