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

Catalog Number 1076400-33

Device Problems Break (1069); Detachment Of Device Component (1104); Positioning Failure (1158); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 12/09/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The xience prox 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 de novo lesion located in the mid circumflex artery that was non-tortuous and non- calcified.After pre-dilatation with a non-abbott balloon, the xience prox 4.0 x 33 mm stent delivery system (sds) was positioned.When the sds was attempted to be inflated, the shaft broke and balloon would only inflate to 4 atmospheres before the pressure fell.When the sds was removed, slight resistance was met with the guide catheter and the shaft separated 30 cm proximal to the distal end.The partially expanded stent slid off the balloon and remained in the vessel.An attempt was made to snare the broken shaft: however, it was not successful.A balloon was then inserted to the end of the guide catheter and the entire sds was removed from the anatomy.Two xience prox stents (4.0 x 18 mm and 3.5 x 23 mm) were used to compress the dislodged stent to the vessel wall.There was no adverse patient sequela.There was no clinically significant delay reported.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported break and detachment were able to be confirmed.The reported stent dislodgement was able to be confirmed.The reported failure to deploy and the reported difficult to remove were unable to be replicated in a testing environment as they were based on operational circumstances.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.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.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE PROX EVEROLIMUS ELUTING RX 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: 6227072
• MDR Text Key: 64017505
• Report Number: 2024168-2017-00127
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2019
• Device Catalogue Number: 1076400-33
• Device Lot Number: 6030841
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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
• Treatment: SHEATH: EBU 4.0 6F
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR