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

Catalog Number 1500225-38

Device Problems Difficult To Position (1467); Difficult to Remove (1528); Unstable (1667); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2018

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.The xience sierra is currently not commercially available in the u.S.; however, it is similar to a device sold in the u.S.

Event Description

It was reported that the procedure was to treat a non-tortuous, non-calcified de novo lesion in the proximal right coronary artery that was 70% stenosed.The patient was admitted with chest pain and angioplasty.During the procedure, the physician created side holes with a needle in an unspecified guiding catheter that was to be used.The lesion was then prepped with an unspecified balloon.A 2.25 x 38mm xience sierra stent delivery system (sds) was attempted to be advanced to the lesion but was unable to because resistance was met with the guiding catheter.Reportedly, the physician thought the resistance was caused by creating side holes in the guide catheter which created a lip that snagged the stent.Resistance was also met during removal of the device.Once the device was withdrawn, it was noted that the stent had elongated and had started to come off of the balloon.A 2.5 x 38mm xience alpine sds was used to successfully complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: the device was returned for analysis.The reported stretched stent - material deformation was confirmed.The unstable stent was not able to be confirmed due to the stent extensive deformation condition.The difficulty to position and to remove were unable to be replicated in a testing environment as they were based on operational circumstances.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 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 design, manufacture 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
• 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: 7229642
• MDR Text Key: 98849991
• Report Number: 2024168-2018-00702
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2020
• Device Catalogue Number: 1500225-38
• Device Lot Number: 7092741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2017
• 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