MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1070300-48

Device Problems Detachment Of Device Component (1104); Deflation Problem (1149); Difficult or Delayed Positioning (1157); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 the procedure was to treat a de novo lesion in a moderately tortuous and heavily calcified mid circumflex artery.A 3.0 x 48 mm xience xpedition stent delivery system (sds) was advanced to the lesion and met resistance with the anatomy.After deployment, the stent showed a waste which was not able to be apposed to the vessel wall.Therefore, there was an attempt to deflate the sds balloon; however, the balloon would not deflate, and the hypotube separated when trying to remove the sds with the inflated balloon from the anatomy.The separated proximal shaft was removed from the anatomy and the patient was sent to surgery to remove the inflated balloon.The patient is stable.There was no adverse patient sequela reported.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned for analysis.The reported detachment of a device component was confirmed.The reported physical resistance, difficulty to deploy and deflation issues could not be tested due to the condition of 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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.The balloon was removed without deflation causing the reported detachment of a device component.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE XPEDITION 48 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: 7397883
• MDR Text Key: 104404941
• Report Number: 2024168-2018-02477
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2020
• Device Catalogue Number: 1070300-48
• Device Lot Number: 7091241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR