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

Catalog Number 1500350-38

Device Problems Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 12/02/2018

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 investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on removal of a 3.50 x 38 mm xience sierra stent delivery system (sds) from the dispenser hoop with no resistance, it was noted that the stent remained tightly crimped, but was positioned incorrectly on the balloon.The sds was not used.There was no patient involvement.The procedure was successfully continued with a new unspecified sierra sds.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Patient codes: 2199 labeled.Device codes: 2976 labeled.(b)(4).Corrections: relevant tests.Patient information.Patient code 2645 and device code 2923 were removed.Evaluation summary: the device was returned for analysis.The reported material deformation (stent flare) 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 was unable to determine a conclusive cause for the reported material deformation (stent flare) based on the information provided.There is no indication of a product quality issue with respect to design, manufacture or labeling.

Event Description

Subsequent to the initially filed report, the following information was received: the 3.50 x 38 mm xience sierra stent delivery system (sds) was advanced over an unspecified guide wire; however, prior to entering the patient anatomy the stent struts were noted to be flared.The stent did not sit incorrectly on the balloon of the sds as previously reported.As the sds did not enter the anatomy there were no adverse patient effects.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: 8185696
• MDR Text Key: 131342130
• Report Number: 2024168-2018-09941
• 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: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/07/2021
• Device Catalogue Number: 1500350-38
• Device Lot Number: 8072742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Date Manufacturer Received: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1