MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO LL SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number 1012015-120

Device Problems Break (1069); Stretched (1601); Device Dislodged or Dislocated (2923); Mechanical Jam (2983); Activation Failure (3270); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2024

Event Type  Injury  

Event Description

(b)(6).It was reported that during recanalization of the chronic total occlusion (cto) of the severely calcified, superficial femoral artery (sfa), during a femoral to femoral crossover case, prior to stent implantation, a perforation was noted in the subintimal plane of the sfa while using the ht command 18 st guidewire.This was treated with manual compression and a balloon dilatation catheter.A balloon dilatation catheter was used proximal to the intraluminal bleeding, and manual compression was applied from medial.These two methods stopped the bleeding.The 6.0x120 mm absolute pro ll self expanding stent delivery system was advanced to the target lesion and deployment was initiated.After 5 mm of stent deployment, there was difficulty rotating the deployment wheel of the delivery system, a ¿crack¿ sound was heard and the delivery system (rotation handle) was not able to rotate any further.The stent failed to deploy after the first 5 mm.During removal of the stent delivery system, the absolute pro ll stent became elongated from sfa to the external iliac artery.The stent was pulled from the delivery system during removal of the delivery system and the stent was partially in the target lesion and partially in healthy tissue.This was treated with in-stent implantation of another stent (supera).The supera stent was required since it was not possible to treat the intended sfa location with the elongated absolute pro ll stent and it was not possible to withdraw (remove) the elongated absolute pro ll stent.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional ht command 18 device referenced in b5 is filed under separate medwatch report number.

Event Description

Subsequent to the previously filed report, additional information was received that the wrong size guidewire was used with the absolute pro ll.A duplicate event for this device was filed under mdr 2024168-2024-02675-00 and 2024168-2024-02675-01.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported physical resistance, difficult/delayed activation, noise, stretched and break were unable to be replicated in a testing environment due to the condition of the returned device.Electronic lot history record (elhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other similar incidents from this lot.Reportedly, an.018 guide wire was used.Use of an undersized guide wire, with insufficient support, may cause kinking in the stent delivery system.It should be noted the absolute pro ll peripheral self-expanding stent system instructions for use (ifu), materials required, states: one 0.035" (0.89 mm) diameter guide wire.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to deviation of the instructions for use and subsequent circumstances of the procedure as it is likely that during advancement use of the undersized.018¿ guide wire in conjunction with interaction with the anatomy resulted in bending the device such that it prevented the shaft lumens from moving freely causing resistance; thus during stent deployment resulted in the reported thumbwheel ¿crack sound¿, the reported thumbwheel physical resistance and ultimately resulted in the reported stent deployment difficulties.Manipulation of the compromised device resulted in the noted wrinkled sheath likely contributing to the reported deployment difficulties.Interaction with the anatomy and/or other devices during retraction of the compromised device resulted in the reported stretched stent as it was inadvertently partially deployed in healthy tissue.As reported, a supera stent was deployed in the target lesion inside the absolute pro stent to complete the procedure.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B5 - describe event or problem - updated.H6 - medical device problem code: codes 2983, 3270 and 2923 were removed and codes 2577, 4012 and 2017 were added.H6- medical device problem code 2017 clarifier: failure to follow steps/instructions.

• Brand Name: ABSOLUTE PRO LL SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18858093
• MDR Text Key: 337130774
• Report Number: 2024168-2024-02915
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012015-120
• Device Lot Number: 3072561
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2023
• 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
• Treatment: GUIDEWIRE: HT COMMAND 18
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 92 KG