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

Catalog Number 1550275-38

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Occlusion (1984)

Event Date 04/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that this was a percutaneous intervention for a proximal circumflex (cx) lesion with in-stent restenosis.Following pre-dilatation, a 2.75x38mm xience sierra stent was implanted.Post implantation, stent under expansion was observed.The proximal and distal half of the stent was tapered, with a distal reference minimal luminal area (mla) <4.5mm.In addition, intra-stent plaque protrusion or thrombus was also reported.As treatment, the maximum size post-dilatation balloon was used.There was no adverse patient sequela reported.No additional information was provided regarding this issue.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.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 difficulty to deploy (wall apposition).There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

Event Description

Subsequent to the initial medwatch report, the additional information was received: there was no plaque or thrombus in the 2.75x38mm xience sierra stent.

• 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: 8616594
• MDR Text Key: 145268568
• Report Number: 2024168-2019-03874
• 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: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2019
• Device Catalogue Number: 1550275-38
• Device Lot Number: 8080741
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER: 6F; GUIDE CATHETER: 6F
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 92