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

Model Number	1550250-33
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a none tortuous, mildly calcified mid-right coronary artery that was 80% stenosed.The 2.50x33mm xience sierra balloon would not inflate.Eventually, the balloon partially inflated.The stent was post-dilated with an unspecified balloon and it remains in the lesion.It was then noted there was a leak from a pinhole in the shaft.There was no adverse patient sequela reported.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported shaft torn material, leak and inflation problems were confirmed.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 was unable to determine a conclusive cause for the reported shaft tear.The reported leak and inflation issues appear to be related to circumstances of the procedure as it is likely the inner member damage caused the leak and subsequent inflation issues (failure to inflate and irregular inflation).There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE SIERRA
• Common Device Name: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9833119
• Report Number: 2024168-2020-02442
• Device Sequence Number: 2871869
• Product Code: NIQ
• UDI-Device Identifier: 08717648227134
• UDI-Public: 08717648227134
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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: 07/28/2020
• Device Model Number: 1550250-33
• Device Catalogue Number: 1550250-33
• Device Lot Number: 9071841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 03/14/2020
• Supplement Report FDA Received Date: 04/30/2020
• 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: 76 YR