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

Catalog Number 1550400-28

Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the procedure was performed to treat a lesion in the heavily calcified mid to distal right coronary artery.Following pre-dilatation with a non-abbott balloon, a 4x28mm xience sierra stent delivery system (sds) was advanced without resistance and air aspiration was performed inside the anatomy.As the stent was being deployed, the balloon ruptured at 12 atmospheres.A pinhole rupture occurred on the proximal side of the balloon, but the sds was removed without resistance.A 4x15mm nc trek balloon was used to perform post-dilatation at 12 atmospheres to fully appose the stent at the intended site and successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Correction: mfr site reg#.Evaluation summary: the device was returned for analysis.The reported material rupture was confirmed.The reported difficulty to deploy the device was unable to be replicated in a testing environment as it was based on operational circumstances.It should be noted that the xience sierra everolimus eluting coronary stent system instruction for use (ifu), lists delivery system preparation to be performed prior to delivery procedure.In this case, it is unknown if the ifu deviation related to prepping the device inside the anatomy contributed to the reported difficulties.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 did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported material rupture; however, factors that may contribute to material ruptures include, but are not limited to, material damage, interactions with other devices or interaction with lesion calcification and tortuosity.Additionally, the reported difficulty to deploy and treatment appear to be related to circumstances of the procedure as it is likely the stent was unable to fully deploy due to the reported material rupture causing the need for post-dilation.There is no indication of a product quality issue with respect to manufacture, design 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
• MDR Report Key: 8680503
• MDR Text Key: 147385604
• Report Number: 2024168-2019-04524
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2021
• Device Catalogue Number: 1550400-28
• Device Lot Number: 8031641
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/03/2019
• Initial Date Manufacturer Received: 05/17/2019
• Initial Date FDA Received: 06/07/2019
• Supplement Dates Manufacturer Received: 07/25/2019
• Supplement Dates FDA Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 87