MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Model Number	1550400-23
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was returned for investigation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a chronic totally occluded, mildly tortuous, and moderately calcified de novo lesion in the right coronary artery.An unspecified guide wire was advanced and pre-dilatation was performed.Two unspecified stents were implanted from peripheral.Following, a 4.0x23mm xience sierra stent delivery system (sds) was advanced.The sds was prepped (air aspirated), while inside the patient anatomy.The balloon of the sds was inflated; however, pressure gradually decreased at 12 atmospheres.A pinhole rupture was suspected.The sds was removed and an unspecified non-compliant balloon catheter was used to post dilate the stent to successfully complete the procedure.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
A visual and functional inspection was performed on the returned device and the reported balloon rupture was confirmed.The reported stent deployment issue was unable to be replicated in a testing environment as it was based on operational circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot and relabeled lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints reported from this lot or relabeled lot.It should be noted that everolimus eluting coronary stent system xience sierra, fda, electronic instructions for use (ifu) states the sds is to be prepped before introducing the sds into the anatomy.In this case, the reported ifu violation does not appear to have caused or contributed to the reported complaint.The investigation determined the reported balloon rupture and activation/expansion failure appears to be related to operational circumstances of the procedure.Based on the reported information, it is likely that during advancement through the anatomy and/or the previously implanted stents, the balloon outer surface became damaged resulting in the reported balloon rupture at 12 atmospheres and stent deployment issues.Additionally, the treatment appears to be related to the operational context of the procedure as an unspecified non-compliant balloon catheter was used to post dilate the stent.The noted bends on the hypotube likely occurred during packing for return analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10388769
• Report Number: 2024168-2020-06658
• Device Sequence Number: 19737805
• Product Code: NIQ
• UDI-Device Identifier: 08717648227516
• UDI-Public: 08717648227516
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/02/2021
• Device Model Number: 1550400-23
• Device Catalogue Number: 1550400-23
• Device Lot Number: 808274A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 09/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR