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

Catalog Number 1120225-12

Device Problems Break (1069); Difficult to Remove (1528); Material Separation (1562); Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2022

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.N/a.

Event Description

It was reported that the procedure was to treat a moderately tortuous, heavily calcified descending artery bifurcating with the diagonal artery.When advancing a 2.25x12mm xience alpine, resistance was met with the anatomy and guide wire and the device failed to cross.During removal of the xience alpine it met resistance with the guide wire.The stent implant was noted as flared and hypotube was noted to be heavily fractured and kinked, but remained in one piece.The device was simply removed altogether with the guide wire.A 2x12mm xience alpine was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Event Description

It was reported that the procedure was to treat a moderately tortuous, heavily calcified descending artery bifurcating with the diagonal artery.When advancing a 2.25x12mm xience alpine, resistance was met with the anatomy and guide wire and the device failed to cross.During removal of the xience alpine it met resistance with the guide wire.The stent implant was noted as flared and hypotube was noted to be heavily fractured and kinked, but remained in one piece.The device was simply removed altogether with the guide wire.A 2x12mm xience alpine was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Device analysis noted that [the separated inner member in between the two inner member separations was not returned] it is unknown if the separated material remains in the anatomy.Subsequent to the initially filed mdr report, the account confirmed that the stent implant dislodged while the device was being advanced due to resistance with anatomy.The dislodged stent was removed from the anatomy over the guide wire, with the guide catheter.No additional information was provided.

Manufacturer Narrative

Type of reportable event changed from malfunction to serious injury health effect clinical code 2199, 4582 were removed.

Manufacturer Narrative

A visual inspection was performed on the returned device.The reported break could not be confirmed.The reported failure to advance could not be tested as it was based on the operational context of the procedure.The reported difficult to advance and difficult to remove could not be tested due to the device condition.The reported material deformation, stent dislodgement, and deformation due to compressive stress were confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported difficult to advance, failure to advance, material deformation, difficult to remove, deformation due to compressive stress, stent dislodgement and the subsequent treatment appear to be related to the operational context of the procedure.A conclusive cause for the reported shaft break could not be determined as it was not confirmed.Additionally, a conclusive cause for the reported patient effect, and its relationship to the product, if any, cannot be determined.In this case, it is likely that the sds interacted with the moderately tortuous, heavily calcified anatomy during advancement, as resistance was noted, causing the reported failure to advance, material deformation (damaged stent), stent dislodgement and noted bunched inner member.Further interaction with the guide wire in addition to the challenging anatomy during advancement/retraction likely contributed to the noted smashed/twisted tip, causing the reported difficult to advance/position and difficult to remove (guide wire resistance).Manipulation of the device during retraction, as resistance was again noted, likely contributed to the reported deformation due to compressive stress (shaft/bent hypotube) in addition to the noted stretched inner/outer member, ultimately causing the noted inner member and balloon separation.Although the reported shaft break was not confirmed, it is possible that the noted inner member and balloon separation was reported as the break; however, this cannot be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling of the device.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13536351
• MDR Text Key: 289468896
• Report Number: 2024168-2022-01557
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2022

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: 06/09/2022
• Device Catalogue Number: 1120225-12
• Device Lot Number: 9060341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/15/2022
• Supplement Dates Manufacturer Received: 03/31/2022; 05/03/2022
• Supplement Dates FDA Received: 04/20/2022; 05/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2019
• 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): Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 62 KG