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

Catalog Number 1125350-12

Device Problems Difficult or Delayed Positioning (1157); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2017

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 not returned for analysis.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 similar incidents from this lot.There is no indication of a product quality issue with respect to manufacture, design or labeling.The 3.0 x 12 and 3.5 x 12 nc travelers referenced in describe event or problem are filed under separate medwatch report numbers.

Event Description

It was reported that the procedure was to treat a moderately tortuous, eccentric, and heavily calcified de novo second diagonal branch artery that was 99% stenosed.A 3.0 x 12 mm nc traveler was used to pre-dilate the lesion, but resistance was met with the lesion during advancement, and the balloon catheter ruptured at 14 atmospheres (atm) during the second inflation.Pre-dilation was therefore done with a non-abbott balloon catheter.Then there was an attempt to deploy a 3.5 x 12 xience alpine stent, but the stent did not expand enough due to the heavy calcification of the lesion.Therefore, post-dilation was attempted with a 3.5 x 12 mm nc traveler.However, resistance was met with the lesion during advancement, and the balloon catheter ruptured at 18 atm during the first inflation.The stent delivery system was then used for post-dilation followed by further post-dilation with a non-abbott balloon catheter.The xience alpine stent was successfully implanted though it was deformed due to the heavy calcification of the lesion.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).Required intervention to prevent permanent impairment/damage(devices) was removed.(b)(4).

• Brand Name: XIENCE ALPINE 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): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 6591845
• MDR Text Key: 76019659
• Report Number: 2024168-2017-04502
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648199516
• UDI-Public: (01)08717648199516(17)171222(10)4121061
• 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,Followup
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/22/2017
• Device Catalogue Number: 1125350-12
• Device Lot Number: 4121061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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