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

Catalog Number 1550275-15

Device Problems Leak/Splash (1354); Peeled/Delaminated (1454); Difficult To Position (1467); Material Deformation (2976); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2018

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 was returned for analysis.The reported material deformation (stent flare) was confirmed.The reported difficulty to position the device was unable to be tested due to the condition the device was returned.Additionally, torn material, a leak and material shredding was noted on the returned device.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 other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the xience sierra device interacted with the other devices which were all within the guiding catheter, causing the reported difficulty to position and subsequent material deformation (stent flare).Additionally, this interaction likely resulted in the noted balloon damage (tear, leak, material shredding).There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

Event Description

It was reported that the procedure was to treat a 90% stenosed, mildly tortuous, and heavily calcified concentric de novo lesion in the proximal circumflex artery.A 2.75x15mm xience sierra stent delivery system (sds) was being advanced; however, strong resistance was felt inside the guiding catheter.The sds was removed from the patient anatomy and the stent struts were noted to be flared.A different 2.75x15mm xience alpine stent was deployed to successfully complete the procedure.There was no reported adverse patient effect or a clinically significant delay in the procedure.Return device analysis revealed that the stent delivery system did not fully inflate as fluid leaked out of a tear and pinhole.Additionally, there was shredded/peeling material near the tear area.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
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7576419
• MDR Text Key: 110462011
• Report Number: 2024168-2018-04253
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227172
• UDI-Public: 08717648227172
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2021
• Device Catalogue Number: 1550275-15
• Device Lot Number: 8030941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1